Analysis system for testing a sample

ABSTRACT

An analysis system and a method for testing a biological sample, wherein an operating instrument is provided which preferably can be separated from an analysis device with respect to a data connection and/or wirelessly connected to the analysis device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a division of commonly-owned, co-pending U.S. patentapplication Ser. No. 15/725,352 filed Oct. 5, 2017, which claims thebenefit of priority to European Patent Application No. 16 020 383.2filed Oct. 7, 2016, the contents of which are incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to an analysis system for testing abiological sample.

Preferably, the present invention deals with analyzing and testing asample, in particular, from a human or animal, particularly preferablyfor analytics and diagnostics, for example with regard to the presenceof diseases and/or pathogens and/or for determining blood counts,antibodies, hormones, steroids or the like. Therefore, the presentinvention is in particular within the field of bioanalytics. A foodsample, environmental sample or another sample may optionally also betested, in particular for environmental analytics or food safety and/orfor detecting other substances.

Preferably, by means of the present invention, at least one analyte(target analyte) of a sample can be determined, identified or detected.In particular, the sample can be tested for qualitatively orquantitatively determining at least one analyte, for example in orderfor it to be possible to detect or identify a disease and/or pathogen.

Within the meaning of the present invention, analytes are in particularnucleic-acid sequences, in particular DNA sequences and/or RNAsequences, and/or proteins, in particular antigens and/or antibodies. Inparticular, by means of the present invention, nucleic-acid sequencescan be determined, identified or detected as analytes of a sample,and/or proteins can be determined, identified or detected as analytes ofthe sample. More particularly preferably, the present invention dealswith systems, devices and other apparatus for carrying out anucleic-acid assay for detecting or identifying a nucleic-acid sequenceand/or a protein assay for detecting or identifying a protein.

The present invention deals in particular with what are known aspoint-of-care systems, i.e., in particular with mobile systems, devicesand other apparatus, and deals with methods for carrying out tests on asample at the sampling site and/or independently and/or away from acentral laboratory or the like. Preferably, point-of-care systems can beoperated autonomously of and/or independently from a mains network forsupplying electrical power.

Description of Related Art

U.S. Pat. No. 5,096,669 discloses a point-of-care system for testing abiological sample, in particular a blood sample. The system comprises asingle-use cartridge and an analysis device. Once the sample has beenreceived, the cartridge is inserted into the analysis device in order tocarry out the test The cartridge comprises a microfluidic system and asensor apparatus comprising electrodes, which apparatus is calibrated bymeans of a calibration liquid and is then used to test the sample.

Furthermore, International Patent Application Publication WO 2006/125767A1 and corresponding U.S. Pat. No. 9,110,044 disclose a point-of-caresystem for integrated and automated DNA or protein analysis, comprisinga single-use cartridge and an analysis device for fully automaticallyprocessing and evaluating molecular-diagnostic analyses using thesingle-use cartridge. The cartridge is designed to receive a sample, inparticular blood, and in particular allows cell disruption, PCR anddetection of PCR amplification products, which are bonded to capturemolecules and provided with a label enzyme, in order for it to bepossible to detect bonded PCR amplification products or nucleicsequences as target analytes in what is known as a redox cyclingprocess.

German Patent DE 100 58 394 C1 and corresponding U.S. Pat. No. 7,838,261disclose a method for testing a sample using a reaction array comprisingat least two reaction compartments for receiving substances that reactwith one another, the reaction compartments being interconnected bymeans of a supply space. In order to measure the substances, an exchangeof substances and thus chemical crosstalk between the individualreaction compartments is prevented by lowering a sensor cover. In thisway, the detection sensitivity of the method is increased.

European Patent Application EP 2 305 383 B1 and corresponding U.S.Patent Application Publication 2008/207461 A1 disclose an instrument forcarrying out and analyzing microarray experiments. In particular, thisdocument discloses carrying out microarray experiments in parallel inorder to detect specific interactions between probe molecules and targetmolecules in a microtiter plate. In this case, probes in the form of asubstance library are provided on carriers, and therefore a sample canbe simultaneously analyzed on a plurality of probes in parallel. In thecontext of microarray experiments of this kind, it is also disclosedthat a desired operating mode can be specified for a processingapparatus externally, in particular by a user.

U.S. Patent Application Publication US 2011/0253224 A1 discloses afeedback control in microfluidic systems. The control of fluids involvesthe use of feedback from one or more processes or events taking place inthe microfluidic system. For instance, a detector may detect one or morefluids at a measurement zone and, using this data, a control system maydetermine whether to modulate subsequent fluid flow in the microfluidicsystem.

U.S. Patent Application Publication US 2015/0148705 A1 discloses systemsand devices for sampling and profiling microbiota of skin. A microbeprofiling device includes a handheld housing with an elongated flexiblestrip including a microbe-capture region and a location informationstorage component The strip is configured to capture microbes from oneor more regions of a skin surface of an individual, and the locationinformation storage component is configured to store informationassociated with the location of said one or more regions.

U.S. Patent Application Publication US 2014/0296089 A1 discloses systemsand methods for multi-analysis and sample processing. A device may beprovided, capable of receiving the sample, and performing one or more ofa sample preparation, sample assay, and detection step. The device maybe capable of performing multiple assays.

German Utility Model DE 20 2010 007 208 U1 discloses a device fortesting of body fluids applied to carrier materials. The devicecomprises at least two apparatus for determining different substancespresent in the body fluid, wherein the carrier materials to be insertedinto the device are provided with a coding specific to the relevant bodyfluid and substance to be determined. The relevant apparatus can beactivated via the corresponding coding. Furthermore, an additionalexternal device can be provided to evaluate and to present measurementresults.

U.S. Patent Application Publication US 2002/0060247 A1 discloses ananalyte test instrument system including data management system and amethod of managing data for a plurality of analyte test instrumentsconnect to a data communication network. The method comprises the stepsof: detecting via a host computer, the connection of each instrument tothe data communication network; uploading data received from eachinstrument to the host computer; processing the uploaded data on thehost computer for operator review; and downloading configuration datafrom the host computer to each test instrument, the downloaded datacomprising instruments specific setup and control data.

Australian Patent Application Publication AU 2013 201509 B2 disclosesPoint-of-Care fluidic systems and uses thereof. Specifically, theinvention provides portable medical devices that allow real-timedetection of analytes from a biological fluid. A system for detecting ananalyte in a bodily fluid comprises a fluidic device in which a sampleof bodily fluid can react with reactants contained within the device,based on a protocol transmitted from an external device, to yield adetectable signal indicative of the presence of said analyte. The systemfurther comprises a reader assembly for detecting said detectablesignal. The external device is external to the reader assembly andstores a plurality of protocols, wherein the reader assembly isconfigured to download a fluidic device-specific protocol selected fromthe plurality of protocols on the external device to run on the fluidicdevice based on an identity of the fluidic device.

U.S. Pat. No. 5,961,451 A discloses a non-invasive apparatus having aretaining member to retain a removable biosensor. The apparatus includesa non-invasive extraction device to non-invasively extract a biologicalsample from an end-user, preferably through the skin by transdermalpermeation. The apparatus further comprises a biosensor to sense acharacteristic, property, or parameter of the biological sample.

U.S. Patent Application Publication US 2006/0292039 A1 discloses ameasuring system making it possible for a user to check his/her ownhealth state at a desired place without visiting inspection agencies.First, a user collects body fluid which is introduced to a chip as asample. The sample is made to act on a detection reagent which acts on aspecific component in the sample to generate a predetermined detectionreaction. The chip is set to a mobile terminal, which measures an amountof a specific component in the sample. The mobile terminal transmits themeasurement value to an analysis center.

U.S. Patent Application Publication US 2015/0244852 A1 discloses anapparatus and method for Point-of-Collection measurement of abiomolecular reaction. A biological sample is collected on a modulardiagnostic test platform, which is inserted into a smartphone accessory.Optical, electrical, mechanical, or other means are used to transduce abiomolecular binding event and communicate the results with thesmartphone. The result can then be presented quantitatively, displayedto the user, stored for later comparison, and communicated to a centralhub location where medical professionals can provide additional review.

SUMMARY OF THE INVENTION

The problem addressed by the present invention is to provide an analysissystem, a method and a computer program product for evaluating a sample,it being possible to test the sample and/or to test measurement resultsin a more efficient, individual and/or flexible manner.

The above problem is solved by an analysis system as described herein.

A proposed analysis system is provided for testing, in particular, abiological sample.

The analysis system is in particular portable, mobile and/or is apoint-of-care system and/or is or can be operated autonomously, inparticular independently from a power network, in particular at thesampling site and/or away from a central laboratory and/or by means of apower storage unit.

The analysis system preferably comprises an analysis device and acartridge for testing the sample, the cartridge preferably beingdesigned for receiving the sample. Particularly preferably, the analysisdevice is designed to receive the cartridge or to connect said cartridgeelectrically, thermally and/or pneumatically. The analysis device ispreferably designed to subsequently carry out the test using thereceived cartridge. For this purpose, the cartridge can be inserted orloaded into the analysis device, whereupon the analysis device can acton the cartridge in order to carry out the test.

Channels in which the sample can be conveyed are preferably provided insaid cartridge. This makes it possible for the sample to be pretreatedor processed on the card and/or for the sample to be evaluated oranalyzed by means of a sensor apparatus, which is preferably alsolocated on the card.

Particularly preferably, the analysis system comprises an operatinginstrument This operating instrument may be or comprise a smartphone,tablet or the like. Therefore, the operating instrument is in particulara portable and/or mobile (terminal) device.

It is preferable for the operating instrument to be separable orseparated from the analysis device physically and/or with respect to adata connection. This can be achieved, for example, by disconnecting orterminating or breaking a data connection between the analysis deviceand the operating instrument, in particular manually or by removing theoperating instrument from the analysis device.

Alternatively, or additionally, it is provided for the operatinginstrument to be connectable or connected to the analysis devicewirelessly and/or via a radio connection or air interface. Particularlypreferably, the operating instrument can be or is automaticallyconnected to and/or disconnected and/or separated from the analysisdevice with respect to a data connection, in particular via what isknown as an ad-hoc data connection or an ad-hoc network, such as aBluetooth connection, which is established and/or configuredautomatically. In addition to the Bluetooth standard, other conventionalshort-range transmission methods, NFC, WPAN or WLAN are also suitable.

By means of the operating instrument, it is preferably possible toachieve the configurations of the analysis device required for the test,and therefore it is not necessary for the analysis device to compriseany complex user interfaces, but rather the analysis device preferablycomprises, at most, an on-off switch and a rudimentary status display(not comprising a screen or the like). This advantageously makes itpossible to use standard hardware that can be configured in a flexiblemanner, such as smartphones or tablets, in order for a user-friendlyconfiguration to be achieved, enabling or facilitating a flexibilitywith regard to the embodiment of the operating instrument and forcorresponding data and interfaces to be updated in a simple andsoftware-based manner.

In this respect, one aspect of the present invention is that theoperating instrument is preferably designed to determine, read out orreceive a cartridge identifier corresponding to the cartridge and, usingthe cartridge identifier, to retrieve from a database controlinformation for carrying out the test, which information is inparticular specific to the cartridge or a batch to which the cartridgeis assigned, and/or to transmit said information to the analysis device.

This aspect is advantageous in that it is thus possible to use controlinformation that is individual, unique and/or specific to the specificcartridge. This control information can incorporate characteristicfeatures of the specific cartridge or a batch of cartridges, relatingfor example to the substances therein, to the suitability for a certaintest, to the use of certain sensor arrangements, or to specificinformation for carrying out the test, wherein the information isadapted to the cartridge, the batch or the like, and contains, forexample, adapted times, temperatures or the like.

In this regard, the use of the operating instrument that can beseparated and/or disconnected from the analysis device and/or wirelesslyconnected to the analysis device is particularly advantageous in thatthe cartridge or the cartridge batch can be identified in a simplemanner and independently from the analysis device, and correspondingcontrol information can, separately and/or disconnected from theanalysis device, also be retrieved and/or stored temporarily, forexample in advance. The control information can then be transmitted tothe analysis device at a later stage, also independently from a linkbetween the operating instrument and the Internet and/or the database.

According to another aspect of the present invention, which can also beimplemented independently, the operating instrument is preferablydesigned to transmit to the analysis device control information forcarrying out the test supported by the cartridge, which information isin particular specific to the cartridge or a batch to which thecartridge is assigned, the analysis device being designed to carry outthe test using the transmitted control information independently fromand/or separately and/or disconnected from the operating instrument.

It is therefore preferable for the analysis system to be configured bythe operating instrument to such an extent that the test of the inparticular biological sample using the cartridge can be started or hasbeen started by the analysis device. It is then not necessary for theoperating instrument to remain permanently connected to the analysisdevice, and therefore the operating instrument can be used in a mannerin which it is separated and/or disconnected from the analysis devicewith respect to a data connection.

This makes it possible to handle and use the operating instrument in aflexible manner and independently from the analysis device, inparticular in cases where the sample is tested for a prolonged period oftime. Another advantage is that the analysis device can operateautonomously following corresponding configuration, and therefore theproper testing of the sample is not dependent on the maintenance of theradio connection between the operating instrument and the analysisdevice, which may be subject to disturbance, but rather the test canadvantageously be carried out in a very robust, reliable anddisturbance-resistant manner as a result of the test not being dependenton the maintenance of the radio connection.

According to another aspect of the present invention, which can also beimplemented independently, the analysis device is designed to receivecontrol information from the operating instrument, which information isin particular specific to the cartridge or a batch to which thecartridge is assigned, to control the testing of the sample in thecartridge using the control information, and to transmit measurementresults determined during the test to the operating instrument withoutany prior evaluation.

It is therefore preferable for the measurement results to be interpretedoutside the analysis device, particularly preferably by the operatinginstrument. Alternatively, evaluation can, however, also take placeexternally, for which purpose the operating instrument can send themeasurement results to a server for example. The analysis device ispreferably not set up to directly interpret the measurement results fromthe test of the sample.

Advantageously, interpreting the measurement results outside theanalysis device, in particular by means of the operating instrument, isadvantageous in that the evaluation methods can be dynamically adaptedwithout having to make any changes to the analysis device. This isparticularly advantageous in the context of the present analysis systembased on cartridges which are separated from the analysis device in aninitial state and are inserted into the analysis device for carrying outthe tests.

In this regard, the present system provides the flexibility of usingdifferent cartridges in order to carry out different tests on differentsamples. Different measurement results can then in turn be interpretedin different ways. Adapting an analysis device to variable conditions ofthis kind is complex and may require that the hardware, after some time,be replaced because the processing capacity is too low or because ofsome other adaptation requirement, even though the mechanical componentsof the analysis device might not actually need to be replaced.

Consequently, it has been found to be particularly advantageous for theanalysis device to be physically separated from the operating instrumentand for the measurement results to be evaluated outside the analysisdevice by means of the operating instrument or via the operatinginstrument, in particular since the operating instrument can be replacedin a simpler and more cost-effective manner and also at more frequentintervals without the complex mechanical system of the analysis devicefor carrying out the test using the cartridge also having to beexchanged.

Another aspect of the present invention, which can also be implementedindependently, likewise relates to the evaluation of the measurementresults. In this respect, it is preferable for the operating instrumentto be designed to determine, read out or receive a cartridge identifiercorresponding to the cartridge and, using the cartridge identifier, toretrieve from a database evaluation information designed for evaluatingmeasurement results determined during the test, which information is inparticular specific to the cartridge or a batch to which the cartridgeis assigned, and to evaluate the measurement results using theevaluation information independently and/or separately and/ordisconnected from the analysis device.

In this regard, it is advantageous that, by identifying the cartridgeusing the cartridge identifier, it is possible to use evaluationinformation which is individual or unique to the cartridge or thecartridge batch. In this respect, it is possible to take into accountproperties of the sample preparation, the cartridge, the environmentalconditions and/or the sensor arrangement or other information that isspecific to the cartridge and conducive to rapid and/or reliableevaluation of the measurement results.

Further advantages have already been explained in the context of themeasurement results being evaluated externally outside the analysisdevice, to which reference is made.

Another advantage is that the measurement results can be evaluated inthe operating instrument in an individual and correspondingly accuratemanner. If the evaluation information is retrieved from the database inadvance and initially stored temporarily in the operating instrument, asis the case in a preferred embodiment, despite the flexible hardwarethere is thus no need for a connection to the Internet or other serversand/or databases for the purpose of evaluating the measurement results.

This is particularly advantageous in connection with the fact that theproposed analysis system is preferably a point-of-care system for use onsite, i.e., in the surroundings of the sampling site. In case of doubt,the proposed analysis system is used for example in the countryside in apigsty or on a mountainous pasture where infrastructural weak points cantypically lead to mobile communication connections or the like not beingreliably available. In this case, it is particularly advantageous forthe measurement results to be evaluated in the operating instrumentoutside of and separately and/or disconnected from the analysis device.

The present invention also relates to a method for testing an inparticular biological sample by means of the analysis system comprisingthe cartridge, the analysis device for receiving the cartridge and theoperating instrument, which is preferably separable and/ordisconnectable from the analysis device with respect to a dataconnection and/or wirelessly connectable to the analysis device withrespect to a data connection.

According to one aspect of the proposed method, which can also beimplemented independently, a cartridge identifier corresponding to thecartridge is determined, read out or received by the operatinginstrument. Using the cartridge identifier, control information isretrieved from a database and/or transmitted to the analysis device. Inthis case, the control information is preferably specific to thecartridge or a batch with which the cartridge is associated, thecartridge or batch corresponding to the cartridge identifier.Furthermore, the control information is designed to control the analysisdevice in order to carry out the test using the cartridge. As a result,the advantages that have already been explained at the outset can beachieved.

In another aspect of the proposed method, which can also be implementedindependently, the operating instrument transmits control information tothe analysis device, the control information preferably being specificto the cartridge or a batch with which the cartridge is associatedand/or being suitable for carrying out the test supported by thecartridge. Furthermore, the analysis device carries out the test usingthe transmitted control information independently and/or separatelyand/or disconnected from the operating instrument. As a result, theadvantages that have already been explained at the outset can beachieved.

According to another aspect of the proposed method, which can also beimplemented independently, the analysis device receives the controlinformation from the operating instrument, which information ispreferably specific to the cartridge and/or batch. The analysis devicecontrols the testing of the sample in the cartridge using the controlinformation. The measurement results determined during the test aretransmitted to the operating instrument without any prior evaluation. Asa result, the advantages that have already been explained at the outsetcan be achieved.

According to another aspect of the proposed method, which can also beimplemented independently, the operating instrument determines, readsout or receives a cartridge identifier corresponding to the cartridge orbatch. Using the cartridge identifier, evaluation information, which ispreferably specific to the cartridge or batch, is retrieved from adatabase, which evaluation information is suitable or designed forevaluating measurement results determined during the test. Using theevaluation information, the measurement results are evaluatedindependently and/or separately and/or disconnected from the analysisdevice. As a result, the advantages that have already been explained atthe outset can be achieved.

As a result, a data connection between the operating instrument and theanalysis device may be provided initially. Subsequently, controlinformation is preferably transmitted to the analysis device. In thiscase, the control information preferably corresponds to a cartridge,which can be or is loaded into the analysis device, or to a batch withwhich the cartridge is associated. Using the control information,testing of a sample received in the cartridge is preferably started.After the test has begun, the operating instrument can be separatedand/or disconnected from the analysis device or the operating instrumentis separated and/or disconnected from the analysis device and the testis continued, preferably brought to an end, by means of the analysisdevice comprising the cartridge and independently from the operatinginstrument. Subsequently, a measurement result, as the result of thetest, can be transmitted to the operating instrument If the operatinginstrument has previously been separated and/or disconnected from theanalysis device, the measurement results are preferably transmittedautomatically once the operating instrument has been reconnected to theanalysis device and/or a data connection between the operatinginstrument and the analysis device has been re-established.

According to another aspect of the present invention, which can also beimplemented independently, the analysis device receives from theoperating instrument the control information specific to the cartridge.The analysis device controls the testing of the sample in the cartridgeusing the control information. The measurement results determined duringthe test are transmitted to the operating instrument without any priorevaluation.

According to another aspect of the present invention, which can also beimplemented independently, the operating instrument determines, readsout or receives an identifier corresponding to the cartridge. Using theidentifier, evaluation information specific to the cartridge isretrieved from a database, which evaluation information is suitable ordesigned for evaluating measurement results determined during the testUsing the evaluation information, the measurement results are evaluatedindependently and/or separately and/or disconnected from the analysisdevice.

Another aspect of the present invention, which can also be implementedindependently, relates to a computer program product comprising programcode means which, when executed, for example, by a processor, computer,microcontroller or one or more other data processing apparatus forexecuting the program code means, in particular of the operatinginstrument and/or the analysis device, cause the method steps or themethod according to the present invention to be carried out

The term “analysis device” is preferably understood to mean aninstrument which is in particular mobile and/or can be used on site,and/or which is designed to chemically, biologically and/or physicallytest and/or analyze a sample or a component thereof, preferably inand/or by means of a cartridge. In particular, the analysis devicecontrols the pretreatment and/or testing of the sample in the cartridge.For this purpose, the analysis device can act on the cartridge, inparticular such that the sample is conveyed, temperature-controlledand/or measured in the cartridge.

The term “cartridge” is preferably understood to mean a structuralapparatus or unit designed to receive, to store, to physically,chemically and/or biologically treat and/or prepare and/or to measure asample, preferably in order to make it possible to detect, identify ordetermine at least one analyte, in particular a protein and/or anucleic-acid sequence, of the sample.

A cartridge within the meaning of the present invention preferablycomprises a fluid system having a plurality of channels, cavities and/orvalves for controlling the flow through the channels and/or cavities.

In particular, within the meaning of the present invention, a cartridgeis designed to be at least substantially planar, flat and/or card-like,in particular is designed as a (micro)fluidic card and/or is designed asa main body or container that can preferably be closed and/or saidcartridge can be inserted and/or plugged into a proposed analysis devicewhen it contains the sample.

The term “operating instrument” is preferably understood to mean anapparatus by means of which the analysis device can be controlled,control information can be transmitted to the analysis device, and/ormeasurement results can be received from the analysis device and/ormeasurement results can be evaluated. Preferably, the operatinginstrument is or forms a user interface for controlling the test and/orthe evaluation or outputting of measurement results.

The operating instrument can alternatively be called operator controlinstrument. The operating instrument preferably is configured to beoperated by an operator (user) for controlling, in particular of theanalysis device, the test and/or the evaluation. Thus, the operatinginstrument is or comprises a user interface for input of commands andtransfer of pieces of control information to the analysis device.

The operating instrument preferably comprises an input apparatus forcontrolling the analysis device, for controlling data transmissionand/or for controlling the evaluation of measurement results.Alternatively, or additionally, the operating instrument comprises anoutput apparatus for outputting, in particular displaying, information,in particular status information, operating elements and/or results. Theoperating instrument preferably comprises a processor, microcontrollerand/or memory for executing a computer program product for datatransmission, for control and/or for evaluating measurement results.

Particularly preferably, the operating instrument is a mobile terminaldevice, in particular for a radio and/or mobile network, such as asmartphone, tablet computer, mobile telephone or the like. The operatinginstrument can preferably be operated independently from a powernetwork, using a power storage means, in particular a (rechargeable)battery, and in a mobile manner, autonomously of and/or independentlyfrom further components of the analysis system, in particular theanalysis device. The operating instrument preferably comprises one ormore interfaces for wireless data communications, in particular a WPANcommunication interface, a WLAN communication interface, a near-fieldcommunication interface, an optical communication interface such as acamera, and/or a mobile radio interface.

The term “test” as used herein preferably means a testprocedure/sequence and/or performing an assay, in particular one,several or all steps for performing an assay to determine one or moreanalytes of a sample. The steps are preferably realized by or within theanalysis system, analysis device and/or cartridge.

An “assay” according to the present invention is preferably aninvestigative procedure for qualitatively and/or quantitativelymeasuring, detecting and/or identifying the presence, amount, and/orfunctional activity of a target entity or analyte of the sample. Theanalyte can, e.g., be a drug, a biological, chemical and/or biochemicalsubstance, and/or a cell in an organism or organic sample. Inparticular, the analyte can be a molecule, a nucleic-acid sequence, aDNA, an RNA and/or a protein.

Preferably, the assay according to the present invention is anucleic-acid assay for detecting or identifying a nucleic-acid sequenceand/or a protein assay for detecting or identifying a protein.

An assay, test or test procedure according to the present inventionaccordingly preferably covers at least one of: controlling actuators ofthe analysis device like a pump drive, temperature control apparatus,and valve actuators; acting on the cartridge or sample; treating thesample; preparing the sample; performing one or more mixing processesand/or reactions with the sample; conveying the sample; and measuringone or more properties of the sample, particularly with the sensorapparatus of the cartridge.

The sensor apparatus or a sensor array thereof preferably comprisesmultiple sensor fields and/or electrodes for specifically bonding and/ordetecting one or more analytes to be detected or measured. Further, thesensor apparatus preferably is configured for electrical orelectrochemical detection of analytes of the sample.

Alternatively, or additionally, the sensor apparatus and/or the sensordevice can be configured for detecting or measuring other or furtheranalytes compounds, material characteristics, or the like withoutspecific bonding and/or by means of optical measurement, impedancemeasurement, capacitance measurement, spectrometric measurement, massspectrometric measurement, or tomography like MRT. In this regard, thesensor apparatus, thus, can be formed by an arrangement enabling suchmeasurement In particular, the sensor apparatus or cartridge or anyother sample carrier of the analysis device or system can comprise orform a cavity having a window for said optical measurement The opticalsensor or the sensor apparatus, such as a spectrometer, can be realizedindependently of the cartridge and/or can form part of the analysisdevice.

In the following, the present invention is explained based primarily onthe sensor apparatus having multiple sensor fields and/or being orcomprising a chip having electrodes for electrochemical detection.However, unless stated or conductible unambiguously to the contrary, itis to be understood that measurement results alternatively oradditionally can be achieved by or can be the outcome of one or more ofthe above mentioned measurement techniques even if not mentionedexplicitly.

An assay, test or test procedure according to the present inventionpreferably starts or begins with the analysis device acting on and/orcontrolling processes on the cartridge and/or the sample. In particular,a test starts or begins with actuators acting on the cartridge. Forexample, a test can start with conveying the sample within thecartridge.

Methods and/or steps performed before insertion or receiving of thecartridge into/by the analysis device and/or before conveying, treatingand/or preparing the sample within said cartridge are preferably notpart of an assay, test or test procedure according to the presentinvention.

The “control information”, thus, preferably is configured to carry outsuch an assay, test or test procedure or to enable the analysis systemor the analysis device to carry out such an assay, test or testprocedure. Preferably, said control information is configured to controlor to define a control sequence or to be used by the analysis device tocarry out said assay, test or test procedure. A “control information”,thus, preferably has instructions being configured for controlling theassay, test or test procedure. In particular, the control information isconfigured to control an assay, test or test procedure by defining stepsor parameters of steps including controlling and/or feedback controllingactuators like the pump drive, the temperature control apparatus andvalve actuators.

The above-mentioned aspects and features of the present invention andthe aspects and features of the present invention that will becomeapparent from the following description and can in principle beimplemented independently from one another, but also in any combinationor order.

Other aspects, advantages, features and properties of the presentinvention will become apparent from the following description of apreferred embodiment with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a proposed analysis system and/or analysisdevice comprising a proposed cartridge received therein;

FIG. 2 is a schematic view of the cartridge;

FIG. 3 is a schematic view of the analysis system; and

FIG. 4 shows a schematic sequence using the analysis system.

DETAILED DESCRIPTION OF THE INVENTION

In the figures, which are only schematic and sometimes not to scale, thesame reference signs are used for the same or similar parts andcomponents, corresponding or comparable properties and advantages beingachieved even if these are not repeatedly described.

FIG. 1 is a highly schematic view of a proposed analysis system 1 andanalysis device 200 for testing an in particular biological sample P,preferably by means of or in an apparatus or cartridge 100.

FIG. 2 is a schematic view of a preferred embodiment of the proposedapparatus or cartridge 100 for testing the sample P. The apparatus orcartridge 100 in particular forms a handheld unit, and in the followingis merely referred to as a cartridge.

The term “sample” is preferably understood to mean the sample materialto be tested, which is in particular taken from a human or animal. Inparticular, within the meaning of the present invention, a sample is afluid, such as saliva, blood, urine or another liquid, preferably from ahuman or animal, or a component thereof. Within the meaning of thepresent invention, a sample may be pretreated or prepared if necessary,or may come directly from a human or animal or the like, for example. Afood sample, environmental sample or another sample may optionally alsobe tested, in particular for environmental analytics, food safety and/orfor detecting other substances, preferably natural substances, but alsobiological or chemical warfare agents, poisons or the like.

Preferably, the analysis system 1 and/or analysis device 200 controlsthe testing of the sample P in particular in or on the cartridge 100and/or is used to evaluate the testing and/or to collect, to processand/or to store measurement results from the test

The analysis system 1 preferably comprises one or more cartridges 100for receiving the sample P. The analysis system 1 preferably comprisesthe analysis device 200 for receiving the cartridge 100 and subsequentlycarrying out the test using the received cartridge 100.

By means of the proposed analysis system 1, analysis device 200 and/orcartridge 100 and/or using the proposed method for testing the sample P,preferably an analyte A of the sample P, in particular a (certain)nucleic-acid sequence and/or a (certain) protein, or particularlypreferably a plurality of analytes A of the sample P, can be determined,identified or detected. Said analytes A are in particular detected,identified and/or measured not only qualitatively, but particularlypreferably also quantitatively.

Therefore, the sample P can in particular be tested for qualitatively orquantitatively determining at least one analyte A, for example in orderfor it to be possible to detect a disease and/or pathogen or todetermine other values, which are important for diagnostics, forexample.

Particularly preferably, a molecular-biological test is made possible bymeans of the analysis system 1 and/or analysis device 200 and/or bymeans of the cartridge 100.

Particularly preferably, a nucleic-acid assay for detecting anucleic-acid sequence, in particular a DNA sequence and/or RNA sequence,and/or a protein assay for detecting a protein, in particular an antigenand/or antibody, are made possible or are carried out

Preferably, the sample P or individual components of the sample P oranalyte A can be amplified if necessary, in particular by means of PCR,and tested, identified or detected in the analysis system 1, analysisdevice 200 and/or in the cartridge 100, and/or for the purpose ofcarrying out the nucleic-acid assay. Preferably, amplification productsof the analyte A or analytes A are thus produced.

In the following, further details are first given on a preferredconstruction of the cartridge 100, with features of the cartridge 100preferably also directly representing features of the analysis system 1,in particular even without any further explicit explanation.

The cartridge 100 is preferably at least substantially planar, flat,plate-shaped and/or card-shaped.

The cartridge 100 preferably comprises an in particular at leastsubstantially planar, flat, plate-shaped and/or card-like main body orsupport 101, the main body or support 101 in particular being made ofand/or injection-molded from plastics material, particularly preferablypolypropylene.

The cartridge 100 preferably comprises at least one film or cover 102for covering the main body 101 and/or cavities and/or channels formedtherein at least in part, in particular on the front, and/or for formingvalves or the like, as shown by dashed lines in FIG. 2.

The analysis system 1 or cartridge 100 or the main body 101 thereof, inparticular together with the cover 102, preferably forms and/orcomprises a fluidic system 103, referred to in the following as thefluid system 103.

The cartridge 100, the main body 101 and/or the fluid system 103 arepreferably at least substantially vertically oriented in the operatingposition and/or during the test, in particular in the analysis device200, as shown schematically in FIG. 1. In particular, the main plane orsurface extension of the cartridge 100 thus extends at leastsubstantially vertically in the operating position.

The cartridge 100 and/or the fluid system 103 preferably comprises aplurality of cavities, in particular at least one receiving cavity 104,at least one metering cavity 105, at least one intermediate cavity106A-G, at least one mixing cavity 107, at least one storage cavity 108,at least one reaction cavity 109A-C, at least one intermediatetemperature-control cavity 110 and/or at least one collection cavity111, as shown in FIG. 1 and FIG. 2.

The cartridge 100 and/or the fluid system 103 also preferably comprisesat least one pump apparatus 112 and/or at least one sensor arrangementor sensor apparatus 113.

Some, most or all of the cavities are preferably formed by chambersand/or channels or other depressions in the cartridge 100 and/or themain body 101, and particularly preferably are covered or closed by thecover 102. However, other structural solutions are also possible.

In the example shown, the cartridge 100 or the fluid system 103preferably comprises two metering cavities 105, a plurality ofintermediate cavities 106A to 106G, a plurality of storage cavities 108Ato 108E and/or a plurality of reaction cavities 109A-C, which canpreferably be loaded separately from one another, in particular a firstreaction cavity 109A, a second reaction cavity 109B and an optionalthird reaction cavity 109C, as can be seen in FIG. 2.

The reaction cavity/cavities 109A-C is/are used in particular to carryout an amplification reaction, in particular PCR, or several, preferablydifferent, amplification reactions, in particular PCRs. It is preferableto carry out several, preferably different, PCRs, i.e., PCRs havingdifferent primer combinations or primer pairs, in parallel and/orindependently and/or in different reaction cavities 109A-C.

To carry out the nucleic-acid assay, preferably nucleic-acid sequences,as analytes A of the sample P, are amplified in the reactioncavity/cavities 109A-C by means of an amplification reaction, inparticular in order to produce amplification products for the subsequentdetection in the sensor arrangement or sensor apparatus 113.

Within the meaning of the present invention, amplification reactions arein particular molecular-biological reactions in which an analyte A, inparticular a nucleic-acid sequence, is amplified/copied and/or in whichamplification products, in particular nucleic-acid products, of ananalyte A are produced. Particularly preferably, PCRs are amplificationreactions within the meaning of the present invention.

“PCR” stands for polymerase chain reaction and is a molecular-biologicalmethod by means of which certain analytes A, in particular portions ofRNA or RNA sequences or DNA or DNA sequences, of a sample P areamplified, preferably in several cycles, using polymerases or enzymes,in particular in order to then test and/or detect the amplificationproducts or nucleic-acid products. If RNA is intended to be testedand/or amplified, before the PCR is carried out, a cDNA is producedstarting from the RNA, in particular using reverse transcriptase. ThecDNA is used as a template for the subsequent PCR.

Preferably, during a PCR, a sample P is first denatured by the additionof heat in order to separate the strands of DNA or cDNA. Preferably,primers or nucleotides are then deposited on the separated singlestrands of DNA or cDNA, and a desired DNA or cDNA sequence is replicatedby means of polymerase and/or the missing strand is replaced by means ofpolymerase. This process is preferably repeated in a plurality of cyclesuntil the desired quantity of the DNA or cDNA sequence is available.

For the PCR, marker primers are preferably used, i.e., primers which(additionally) produce a marker or a label, in particular biotin, on theamplified analyte A or amplification product. This allows or facilitatesdetection. Preferably, the primers used are biotinylated and/or compriseor form in particular covalently bonded biotin as the label.

The amplification products and/or other portions of the sample Pproduced in the one or more reaction cavities 109A-C can be conducted orfed to the connected sensor arrangement or sensor apparatus 113, inparticular by means of the pump apparatus 112.

The sensor apparatus 113 is used in particular for detecting,particularly preferably qualitatively and/or quantitatively determining,the analyte A or analytes A of the sample P, in this case particularlypreferably the nucleic-acid sequences and/or proteins as the analytes A.Alternatively or additionally, however, other values may also becollected or determined.

As already explained at the outset, in particular nucleic-acidsequences, preferably DNA sequences and/or RNA sequences, and/orproteins, in particular antigens and/or antibodies, are preferablyqualitatively and/or quantitatively determined as analytes A of thesample P. In the following, however, a distinction is not made betweennucleic-acid sequences and proteins, or between the nucleic-acid assayfor detecting nucleic-acid sequences and the protein assay for detectingproteins.

In particular, the pump apparatus 112 comprises or forms a tube-like orbead-like raised portion, in particular by means of the film or cover102, particularly preferably on the back of the cartridge 100, as shownschematically in FIG. 1.

The cartridge 100, the main body 101 and/or the fluid system 103preferably comprise a plurality of channels 114 and/or valves 115A,115B, as shown in FIG. 2.

By means of the channels 114 and/or valves 115A, 115B, the cavities 104to 111, the pump apparatus 112 and/or the sensor arrangement and/orsensor apparatus 113 can be temporarily and/or permanently fluidicallyinterconnected and/or fluidically separated from one another, asrequired and/or optionally or selectively, in particular such that theyare controlled by the analysis system 1 or the analysis device 200.

The cavities 104 to 111 are preferably each fluidically linked orinterconnected by a plurality of channels 114. Particularly preferably,each cavity is linked or connected by at least two associated channels114, in order to make it possible for fluid to fill, flow through and/ordrain from the respective cavities as required.

The fluid transport or the fluid system 103 is preferably not based oncapillary forces, or is not exclusively based on said forces, but inparticular is essentially based on the effects of gravity and/or pumpingforces and/or compressive forces and/or suction forces that arise, whichare particularly preferably generated by the pump or pump apparatus 112.In this case, the flows of fluid or the fluid transport and the meteringare controlled by accordingly opening and closing the valves 115A, 115Band/or by accordingly operating the pump or pump apparatus 112, inparticular by means of a pump drive 202 of the analysis device 200.

Preferably, each of the cavities 104 to 110 has an inlet at the top andan outlet at the bottom in the operating position. Therefore, ifrequired, only liquid from the respective cavities can be removed viathe outlet.

In the operating position, the liquids from the respective cavities arepreferably removed, in particular drawn out, via the outlet that is atthe bottom in each case, it preferably being possible for gas or air toflow and/or be pumped into the respective cavities via the inlet that isin particular at the top. In particular, relevant vacuums in thecavities can thus be prevented or at least minimized when conveying theliquids.

In particular, the cavities, particularly preferably the storagecavity/cavities 108, the mixing cavity 107 and/or the receiving cavity104, are each dimensioned and/or oriented in the normal operatingposition such that, when said cavities are filled with liquid, bubblesof gas or air that may potentially form rise upwards in the operatingposition, such that the liquid collects above the outlet withoutbubbles. However, other solutions are also possible here.

The receiving cavity 104 preferably comprises a connection 104A forintroducing the sample P. In particular, the sample P may for example beintroduced into the receiving cavity 104 and/or cartridge 100 via theconnection 104A by means of a pipette, syringe or other instrument

The receiving cavity 104 preferably comprises an inlet 104B, an outlet104C and an optional intermediate connection 104D, it preferably beingpossible for the sample P or a portion thereof to be removed and/orconveyed further via the outlet 104C and/or the optional intermediateconnection 104D. Gas, air or another fluid can flow in and/or be pumpedin via the inlet 104B, as already explained.

Preferably, the sample P or a portion thereof can be removed, optionallyand/or depending on the assay to be carried out, via the outlet 104C orthe optional intermediate connection 104D of the receiving cavity 104.In particular, a supernatant of the sample P, such as blood plasma orblood serum, can be conducted away or removed via the optionalintermediate connection 104D, in particular for carrying out the proteinassay.

Preferably, at least one valve 115A, 115B is assigned to each cavity,the pump apparatus 112 and/or the sensor apparatus 113 and/or isarranged upstream of the respective inlets and/or downstream of therespective outlets.

Preferably, the cavities 104 to 111 or sequences of cavities 104 to 111,through which fluid flows in series or in succession for example, can beselectively released and/or fluid can selectively flow there-through bythe assigned valves 115A, 115B being actuated, and/or said cavities canbe fluidically connected to the fluid system 103 and/or to othercavities.

In particular, the valves 115A, 115B are formed by the main body 101 andthe film or cover 102 and/or are formed in another manner, for example,by additional layers, depressions or the like.

Particularly preferably, one or more valves 115A are provided which arepreferably tightly closed initially or in the storage state,particularly preferably in order to seal liquids or liquid reagents F,located in the storage cavities 108, and/or the fluid system 103 fromthe open receiving cavity 104 in a storage-stable manner.

Preferably, an initially closed valve 115A is arranged upstream anddownstream of each storage cavity 108. Said valves are preferably onlyopened, in particular automatically, when the cartridge 100 is actuallybeing used and/or while inserting the cartridge 100 into the analysisdevice 200 and/or for carrying out the assay.

A plurality of valves 115A, in particular three valves in this case, arepreferably assigned to the receiving cavity 104, in particular if theintermediate connection 104D is provided in addition to the inlet 104Band the outlet 104C. Depending on the use, in addition to the valve 115Aon the inlet 104B, then preferably only the valve 115A either at theoutlet 104C or at the intermediate connection 104D is opened.

The valves 115A assigned to the receiving cavity 104 seal the fluidsystem 103 and/or the cartridge 100 in particular fluidically and/or ina gas-tight manner until the sample P is inserted and the receivingcavity 104 or a connection 104A of the receiving cavity 104 is closed.

As an alternative or in addition to the valves 115A (which are initiallyclosed), one or more valves 115B are preferably provided which are notclosed in a storage-stable manner and/or which are open initially and/orwhich can be closed by actuation. These valves are used in particular tocontrol the flows of fluid during the test.

The cartridge 100 is preferably designed as a microfluidic card and/orthe fluid system 103 is preferably designed as a microfluidic system. Inthe present invention, the term “microfluidic” is preferably understoodto mean that the respective volumes of individual cavities, some of thecavities or all of the cavities 104 to 111 and/or channels 114 are,separately or cumulatively, less than 5 ml or 2 ml, particularlypreferably less than 1 ml or 800 μl, in particular less than 600 μl or300 μl, more particularly preferably less than 200 μl or 100 μl.

Particularly preferably, a sample P having a maximum volume of 5 ml, 2ml or 1 ml can be introduced into the cartridge 100 and/or the fluidsystem 103, in particular the receiving cavity 104.

Reagents and liquids which are preferably introduced or provided beforethe test in liquid form as liquids or liquid reagents F and/or in dryform as dry reagents S are required for testing the sample P, as shownin the schematic view according to FIG. 2 by reference signs F1 to F5and S1 to S10.

Furthermore, other liquids F, in particular in the form of a washbuffer, solvent for dry reagents S and/or a substrate, for example inorder to form detection molecules and/or a redox system, are alsopreferably required for the test, the detection process and/or for otherpurposes, and are in particular provided in the cartridge 100, i.e., arelikewise introduced before use, in particular before delivery. At somepoints in the following, a distinction is not made between liquidreagents and other liquids, and therefore the respective explanationsare accordingly also mutually applicable.

The analysis system 1 or the cartridge 100 preferably contains all thereagents and liquids required for pretreating the sample P and/or forcarrying out the test or assay, in particular for carrying out one ormore amplification reactions or PCRs, and therefore, particularlypreferably, it is only necessary to receive the optionally pretreatedsample P.

The cartridge 100 or the fluid system 103 preferably comprises a bypass114A that can optionally be used, in order for it to be possible, ifnecessary, to conduct or convey the sample P or components thereof pastthe reaction cavities 109A-C and/or, by bypassing the optionalintermediate temperature-control cavity 110, also directly to the sensorapparatus 113.

The cartridge 100, the fluid system 103 and/or the channels 114preferably comprise sensor portions 116 or other apparatus for detectingliquid fronts and/or flows of fluid.

It is noted that various components, such as the channels 114, thevalves 115A, 115B, in particular the valves 115A that are initiallyclosed and the valves 115B that are initially open, and the sensorportions 116 in FIG. 2 are, for reasons of clarity, only labelled insome cases, but the same symbols are used in FIG. 2 for each of thesecomponents.

The collection cavity 111 is preferably used for receiving excess orused reagents and liquids and volumes of the sample, and/or forproviding gas or air in order to empty individual cavities and/orchannels.

In particular, the collection cavity 111 can optionally be connected toindividual cavities and channels or other apparatus fluidically in orderto remove reagents and liquids from said cavities, channels or otherapparatus and/or to replace said reagents and liquids with gas or air.The collection cavity 111 is preferably given appropriate largedimensions.

Once the sample P has been introduced into the receiving cavity 104 andthe connection 104A has been closed, the cartridge 100 can be insertedinto and/or received in the proposed analysis device 200 in order totest the sample P, as shown in FIG. 1. Alternatively, the sample P couldalso be fed in later.

FIG. 1 shows the analysis system 1 in a ready-to-use state for carryingout a test or assay on the sample P received in the cartridge 100,and/or in the operating position. In this state, the cartridge 100 istherefore linked to, received by and/or inserted into the analysisdevice 200.

In the following, some features and aspects of the analysis device 200are first explained in greater detail, in particular on the basis ofFIG. 1. The features and aspects relating to said device are preferablyalso directly features and aspects of the proposed analysis system 1, inparticular even without any further explicit explanation.

The analysis system 1 or analysis device 200 preferably comprises amount or receptacle 201 for mounting and/or receiving the cartridge 100.

Preferably, the cartridge 100 is fluidically, in particularhydraulically, separated or isolated from the analysis device 200. Inparticular, the cartridge 100 forms a preferably independent and inparticular closed or sealed fluidic or hydraulic system 103 for thesample P and the reagents and other liquids. In this way, the analysisdevice 200 does not come into direct contact with the sample P and canin particular be reused for another test without being disinfectedand/or cleaned first.

It is however provided that the analysis device 200 can be connected orcoupled mechanically, electrically, thermally and/or pneumatically tothe cartridge 100.

In particular, the analysis device 200 is designed to have a mechanicaleffect, in particular for actuating the pump apparatus 112 and/or thevalves 115A, 115B, and/or to have a thermal effect, in particular fortemperature-controlling the reaction cavity/cavities 109A-C and/or theintermediate temperature-control cavity 110.

In addition, the analysis device 200 can preferably be pneumaticallyconnected to the cartridge 100, in particular in order to actuateindividual apparatus, and/or can be electrically connected to thecartridge 100, in particular in order to collect and/or transmitmeasured values or measurement results 713, for example from the sensorapparatus 113 and/or sensor portions 116.

The analysis system 1 or analysis device 200 preferably comprises a pumpdrive 202, the pump drive 202 in particular being designed formechanically actuating the pump apparatus 112.

Preferably, a head of the pump drive 202 can be rotated in order torotationally axially depress the preferably bead-like raised portion ofthe pump apparatus 112. Particularly preferably, the pump drive 202 andpump apparatus 112 together form a pump, in particular in the manner ofa hose pump or peristaltic pump and/or a metering pump, for the fluidsystem 103 and/or the cartridge 100.

Particularly preferably, the pump is constructed as described in GermanPatent DE 10 2011 015 184 B4 and corresponding U.S. Pat. No. 8,950,424.However, other structural solutions are also possible.

Preferably, the capacity and/or discharge rate of the pump can becontrolled and/or the conveying direction of the pump and/or pump drive202 can be switched. Preferably, fluid can thus be pumped forwards orbackwards as desired.

The analysis system 1 or analysis device 200 preferably comprises aconnection apparatus 203 for in particular electrically and/or thermallyconnecting the cartridge 100 and/or the sensor arrangement or sensorapparatus 113.

As shown in FIG. 1, the connection apparatus 203 preferably comprises aplurality of electrical contact elements 203A, the cartridge 100, inparticular the sensor arrangement or sensor apparatus 113, preferablybeing electrically connected or connectable to the analysis device 200by the contact elements 203A.

The analysis system 1 or analysis device 200 preferably comprises one ormore temperature-control apparatus for temperature-controlling thecartridge 100 and/or having a thermal effect on the cartridge 100, inparticular for heating and/or cooling, the temperature-control apparatus(each) preferably comprising or being formed by a heating resistor or aPeltier element

Individual temperature-control apparatus, some of these apparatus or allof these apparatus can preferably be positioned against or abutted onthe cartridge 100, the main body 101, the cover 102, the sensorarrangement, sensor apparatus 113 and/or individual cavities and/or canbe thermally coupled thereto and/or can be integrated therein and/or inparticular can be operated or controlled electrically by the analysisdevice 200. In the example shown, in particular the temperature-controlapparatus 204A-C are provided.

Preferably, the temperature-control apparatus, referred to in thefollowing as the reaction temperature-control apparatus 204A, isassigned to one of the reaction cavities 109A-C or to a plurality ofreaction cavities 109A-C, in particular in order for it to be possibleto carry out one or more amplification reactions therein.

The reaction cavities 109A-C are preferably temperature-controlledsimultaneously and/or uniformly, in particular by means of one commonreaction temperature-control apparatus 204A or two reactiontemperature-control apparatus 204A.

More particularly, preferably, the reaction cavity/cavities 109A-C canbe temperature-controlled from two different sides and/or by means oftwo or the reaction temperature-control apparatus 204A that arepreferably arranged on opposite sides.

Alternatively, each reaction cavity 109A-C can be temperature-controlledindependently and/or individually.

The temperature-control apparatus, referred to in the following as theintermediate temperature-control apparatus 204B, is preferably assignedto the intermediate temperature-control cavity 110 and/or is designed to(actively) temperature-control or heat the intermediatetemperature-control cavity 110 and/or a fluid located therein, inparticular the amplification products, preferably to a preheattemperature.

The intermediate temperature-control cavity 110 and/or intermediatetemperature-control apparatus 204B is preferably arranged upstream of or(immediately) before the sensor arrangement or sensor apparatus 113, inparticular in order for it to be possible to temperature-control orpreheat, in a desired manner, fluids to be fed to the sensor arrangementor sensor apparatus 113, in particular analytes A and/or amplificationproducts, particularly preferably immediately before said fluids arefed.

Particularly preferably, the intermediate temperature-control cavity 110or intermediate temperature-control apparatus 204B is designed orprovided to denature the sample P or analytes A and/or the amplificationproducts produced, and/or to divide any double-stranded analytes A oramplification products into single strands and/or to counteractpremature bonding or hybridizing of the amplification products, inparticular by the addition of heat

Preferably, the analysis system 1, analysis device 200 and/or thecartridge 100 and/or one or each temperature-control apparatuscomprise/comprises a temperature detector and/or temperature sensor (notshown), in particular in order to make it possible to control and/orfeedback control temperature.

One or more temperature sensors may for example be assigned to thesensor portions 116 and/or to individual channel portions or cavities,i.e., may be thermally coupled thereto.

The temperature-control apparatus 204C, referred to in the following asthe sensor temperature-control apparatus 204C, is in particular assignedto the sensor apparatus 113 and/or is designed to (actively)temperature-control or heat fluids located in or on the sensorarrangement or sensor apparatus 113, in particular analytes A and/oramplification products, reagents or the like, in a desired manner,preferably to a hybridization temperature.

The sensor temperature-control apparatus 204C is preferably planarand/or has a contact surface which is preferably rectangular and/orcorresponds to the dimensions of the sensor arrangement or sensorapparatus 113, the contact surface allowing for heat transfer betweenthe sensor temperature-control apparatus 204C and the sensor apparatus113.

Preferably, the analysis device 200 comprises the sensortemperature-control apparatus 204C. However, other structural solutionsare also possible in which the sensor temperature-control apparatus 204Cis integrated in the cartridge 100, in particular the sensor arrangementor sensor apparatus 113.

Particularly preferably, the connection apparatus 203 comprises thesensor temperature-control apparatus 204C, and/or the connectionapparatus 203 together with the sensor temperature-control apparatus204C can be linked to, in particular pressed against, the cartridge 100,in particular the sensor arrangement or sensor apparatus 113.

More particularly preferably, the connection apparatus 203 and thesensor temperature-control apparatus 204C (together) can be movedtowards and/or relative to the cartridge 100, in particular the sensorarrangement or sensor apparatus 113, and/or can be positioned againstsaid cartridge, preferably in order to both electrically and thermallycouple the analysis device 200 to the cartridge 100, in particular thesensor arrangement or sensor apparatus 113 or the support thereof.

Preferably, the sensor temperature-control apparatus 204C is arrangedcentrally on the connection apparatus 203 or a support thereof and/or isarranged between the contact elements 203A.

In particular, the contact elements 203A are arranged in an edge regionof the connection apparatus 203 or a support thereof or are arrangedaround the sensor temperature-control apparatus 204C, preferably suchthat the connection apparatus 203 is connected or connectable to thesensor apparatus 113 thermally in the center and electrically on theoutside or in the edge region. However, other solutions are alsopossible here.

The analysis system 1 or analysis device 200 preferably comprises one ormore valve actuators 205A, B for actuating the valves 115A, 115B.Particularly preferably, different (types or groups of) valve actuators205A and 205B are provided which are assigned to the different (types orgroups of) valves 115A and 115B for actuating each of said valves,respectively.

The analysis system 1 or analysis device 200 preferably comprises acontrol apparatus 207 for controlling the sequence of a test or assayand/or for collecting, evaluating and/or outputting or providingmeasured values or measurement results 713, in particular from thesensor apparatus 113, and/or from test results and/or other data orvalues.

The control apparatus 207 preferably comprises an internal clock or timebase by means of which the sequence of the test is or can be controlledand/or by means of which test steps that follow temporally one anotheror that extend over time are controlled or can be controlled by thecontrol apparatus 207.

The control apparatus 207 preferably controls or is designed to controlactuators of the analysis device 200 for acting on the cartridge 100 inorder to carry out the test. The actuators are in particular the pumpdrive 202, the temperature-control apparatus and/or the valve actuators205A, B.

The analysis system 1 or analysis device 200 preferably comprises one ormore sensors 206A-H. In particular, fluid sensors 206A are designed orprovided to detect liquid fronts and/or flows of fluid in the fluidsystem 103. Particularly preferably, the fluid sensors 206A are designedto measure or detect, for example optically and/or capacitively, aliquid front and/or the presence, the speed, the mass flow rate/volumeflow rate, the temperature and/or another value of a fluid in a channeland/or a cavity, in particular in a respectively assigned sensor portion116, which is in particular formed by a planar and/or widened channelportion of the fluid system 103.

The fluid sensor 206A preferably measures a fluid entering or leavingthe sensor portion 116 and/or a content change or fluid change in thesensor portion 116, and in the process generates a measurement result706A that corresponds to the fluid entering, the fluid leaving, thecontent change and/or the fluid change in the sensor portion 116. Thismeasurement result 706A from the fluid sensor 206A can be retrieved bythe control apparatus 207 and/or transmitted to the control apparatus207. The control apparatus 207 controls or is designed to control thetest and/or the actuators, preferably using or taking into account themeasurement result 706A from the fluid sensor 206A. In particular, whena content change, an entering fluid, a leaving fluid and/or a fluidchange is detected in the sensor portion 116, in particular when aliquid front is detected, the control apparatus 207 influences a programsequence. In this case, for example a check can be carried out or asubsequent step of the test can be controlled, in particular byactivating the actuators in a particular and/or differing manner.

Particularly preferably, the sensor portions 116 are each orientedand/or incorporated in the fluid system 103 and/or fluid flows againstor through the sensor portions 116 such that, in the operating positionof the cartridge 100, fluid flows through the sensor portions 116 in thevertical direction and/or from the bottom to the top, or vice versa, inparticular in order to make it possible or easier to accurately detectliquid.

Alternatively, or additionally, the analysis device 200 preferablycomprises one or more (different, other and/or further) sensors 206B.

Preferably, the other sensor 206B is or comprises a pressure sensor fordetermining the (relative) air pressure. The other sensor 206B cangenerate a measurement result 706B, which corresponds in particular tothe air pressure. This measurement result 706B can be retrieved by thecontrol apparatus 207 and/or transmitted to the control apparatus 207.The control apparatus 207 controls or is designed to control the testand/or the actuators, preferably using or taking into account themeasurement result 706B from the other sensor 206B.

Alternatively or additionally, one or more temperature sensors 206C areprovided for detecting the internal temperature and/or the temperaturein the interior space 212A of the analysis device 200, in particular thetemperature of an atmosphere in the interior space 212A. Alternativelyor additionally, one or more temperature sensors 206C are provided fordetecting the ambient temperature and/or the temperature of anatmosphere surrounding the analysis device 200 and/or the temperature ofone or more of the temperature apparatus.

The temperature sensor 206C preferably measures a temperature, inparticular of the interior space 212A of the analysis device 200, and inthe process generates a measurement result 706C that corresponds to thetemperature, in particular of the interior space 212A and/or atmosphereof or parts of the interior space 212A. This measurement result 706Cfrom the temperature sensor 206C can be retrieved by the controlapparatus 207 and/or transmitted to the control apparatus 207. Thecontrol apparatus 207 controls or is designed to control the test and/orthe actuators, preferably using or taking into account the measurementresult 706C from the temperature sensor 206C.

The analysis device 200 preferably comprises a tilt sensor 206D fordetecting the inclination and/or orientation of the analysis device 200and/or of the cartridge 100. The tilt sensor 206D is in particulardesigned and set up to determine the inclination of the analysis device200 and/or of the cartridge 100 that differs from that in an operatingposition.

The tilt sensor 206D preferably measures the inclination, and in theprocess generates a measurement result 706D that corresponds to theinclination of the analysis device 200 and/or of the cartridge 100. Thismeasurement result 706D from the tilt sensor 206D can be retrieved bythe control apparatus 207 and/or transmitted to the control apparatus207. The control apparatus 207 controls or is designed to control thetest and/or the actuators, preferably using or taking into account themeasurement result 706D from the tilt sensor 206D. In particular, if theinclination is too great, the testis prevented, blocked or interrupted,and/or an error is identified, processed, transmitted and/or signaled.

The analysis device 200 may comprise an acceleration sensor 206E. Theacceleration sensor 206E is preferably designed to determine anacceleration of the analysis device 200, in particular an accelerationin the vertical and/or horizontal direction with respect to theoperating position.

The acceleration sensor 206E preferably measures the acceleration, andin the process generates a measurement result 706E that corresponds tothe acceleration of the analysis device 200 and/or of the cartridge 100.This measurement result 706E from the acceleration sensor 206E can beretrieved by the control apparatus 207 and/or transmitted to the controlapparatus 207. The control apparatus 207 controls or is designed tocontrol the test and/or the actuators, preferably using or taking intoaccount the measurement result 706E from the acceleration sensor 206E.In particular, if the acceleration is too great, the test is prevented,blocked or interrupted, and/or an error is identified, processed,transmitted and/or signaled.

The analysis device 200 may comprise a humidity sensor 206F fordetermining the (relative) atmospheric humidity and/or the dew point ofthe atmosphere inside or in the interior space 212A and/or outside theanalysis device 200.

The humidity sensor 206F preferably measures the (relative) atmospherichumidity and/or the dew point, and in the process generates ameasurement result 706F that corresponds to the (relative) atmospherichumidity and/or the dew point of the atmosphere in the analysis device200 and/or the surroundings of the analysis device 200. This measurementresult 706F from the humidity sensor 206F can be retrieved by thecontrol apparatus 207 and/or transmitted to the control apparatus 207.The control apparatus 207 controls or is designed to control the testand/or the actuators, preferably using or taking into account themeasurement result 706F from the humidity sensor 206F. In particular, ifthe (relative) atmospheric humidity is too high and/or if the dew pointis approached or reached, the test is prevented, blocked or interrupted,and/or an error is identified, processed, transmitted and/or signaled.

The analysis device 200 may comprise a position sensor 206G fordetermining the position or location, for example by means of a GPSsensor. The position sensor 206G is preferably designed to determine thelocation of the analysis device 200 in space, in particular on theEarth's surface, and/or to output the geographical position, thelocation and/or the coordinates of the analysis device 200.

The position sensor 206G preferably measures the position, in particularthe geographical position, of the analysis device 200, and in theprocess generates a measurement result 706G that corresponds to theposition or geographical position. This measurement result 706G from theposition sensor 206G can be retrieved by the control apparatus 207and/or transmitted to the control apparatus 207. The control apparatus207 controls or is designed to control the test and/or the actuators,preferably using or taking into account the measurement result 706G fromthe position sensor 206G.

The analysis device 200 may comprise a cartridge sensor 206H fordetermining or checking the position or alignment of the cartridge 100in or with respect to the analysis device 200. In particular, thecartridge sensor 206H is designed to detect an incorrect position of thecartridge 100 in the analysis device 200. Alternatively, oradditionally, the cartridge sensor 206H is designed to detect and/orverify the correct and/or operating position of the cartridge 100 in theanalysis device 200.

The cartridge sensor 206H preferably measures the position of thecartridge 100 in the analysis device 200, and in the process generates ameasurement result 706H that corresponds to the position or alignment ofthe cartridge 100 in the analysis device 200. This measurement result706H from the cartridge sensor 206H can be retrieved by the controlapparatus 207 and/or transmitted to the control apparatus 207. Thecontrol apparatus 207 controls or is designed to control the test and/orthe actuators, preferably using or taking into account the measurementresult 706H from the cartridge sensor 206H. In particular, if thecartridge 100 is incorrectly positioned in the analysis device 200, thetest is prevented or blocked and/or the cartridge 100 is automaticallyejected from the analysis device 200 or the like. Alternatively, oradditionally, the testis enabled if it is detected that the cartridge100 is in the correct operating position in the analysis device 200.

The control apparatus 207 preferably controls or feedback controls thepump drive 202, the temperature-control apparatus 204 and/or the valveactuators 205, in particular taking into account or depending on thedesired test and/or measured values from the sensor arrangement orsensor apparatus 113 and/or sensors 206A-H.

The flows of fluid are controlled in particular by accordinglyactivating the pump or pump apparatus 112 and actuating the valves 115A,115B.

Particularly preferably, the pump drive 202 comprises a stepper motor,or a drive calibrated in another way, such that desired metering can beachieved, at least in principle, by means of appropriate activation.

Additionally, or alternatively, the fluid sensors 206A are used todetect liquid fronts or flows of fluid, in particular in cooperationwith the assigned sensor portions 116, in order to achieve the desiredfluidic sequence and the desired metering by accordingly controlling thepump or pump apparatus 112 and accordingly activating the valves 115A,115B.

Optionally, the analysis system 1 or analysis device 200 comprises aninput apparatus 208, such as a keyboard, a touch screen or the like,and/or a display apparatus 209, such as a screen.

The analysis system 1 or analysis device 200 preferably comprises atleast one interface 210, for example for controlling, for communicatingand/or for outputting measured data or test results and/or for linkingto other devices, such as a printer, an external power supply or thelike. This may in particular be a wired or wireless interface 210.

The analysis system 1 or analysis device 200 preferably comprises apower supply 211, preferably a battery or an accumulator, which is inparticular integrated and/or externally connected or connectable.

Preferably, an integrated accumulator is provided as a power supply 211and can be (re)charged by an external charging device (not shown) via aconnection 211A and/or is interchangeable.

The analysis system 1 or analysis device 200 preferably comprises ahousing 212, all the components and/or some or all of the apparatuspreferably being integrated in the housing 212. Particularly preferably,the cartridge 100 can be inserted or slid into the housing 212, and/orcan be received by the analysis device 200, through an opening 213 whichcan in particular be closed, such as a slot or the like.

The analysis system 1 or analysis device 200 is preferably portable ormobile. Particularly preferably, the analysis device 200 weighs lessthan 25 kg or 20 kg, particularly preferably less than 15 kg or 10 kg,in particular less than 9 kg or 6 kg.

The fluidic, in particular pneumatic, coupling between the cartridge 100and the analysis device 200 will be explained in greater detail in thefollowing, it being possible for the following aspects to be implementedindependently from the preceding aspects.

As already explained, the analysis device 200 can preferably bepneumatically linked to the cartridge 100, in particular to the sensorarrangement or sensor apparatus 113 and/or to the pump apparatus 112.

Particularly preferably, the analysis device 200 is designed to supplythe cartridge 100, in particular the sensor arrangement or sensorapparatus 113 and/or the pump apparatus 112, with a working medium, inparticular gas or air.

Preferably, the working medium can be compressed and/or pressurized inthe analysis device 200 or by means of the analysis device 200.

Preferably, the analysis device 200 comprises a pressurized gas supply214 for this purpose, in particular a pressure generator or compressor,preferably in order to compress and/or pressurize the working medium.

The pressurized gas supply 214 is preferably integrated in the analysisdevice 200 or the housing 212 and/or can be controlled or feedbackcontrolled by means of the control apparatus 207. The pressurized gassupply 214 can also, at least in part, be formed on or by the cartridge100.

Preferably, the pressurized gas supply 214 is electrically operated orcan be operated by electrical power. In particular, the pressurized gassupply 214 can be supplied with electrical power by means of the powersupply 211.

The analysis device 200 or pressurized gas supply 214 is preferablydesigned to compress the working medium to a pressure of more than 100kPa, particularly preferably more than 150 kPa or 250 kPa, in particularmore than 300 kPa or 350 kPa, and/or of less than 1 MPa, particularlypreferably less than 900 kPa or 800 kPa, in particular less than 700 kPaand/or to feed said medium to the cartridge 100 at said pressure.

Preferably, air can be drawn in, in particular from the surroundings, asthe working medium by means of the analysis device 200 or pressurizedgas supply 214. In particular, the analysis device 200 or pressurizedgas supply 214 is designed to use the surroundings as a reservoir forthe working medium or the air. However, other solutions are alsopossible here, in particular those in which the analysis device 200 orpressurized gas supply 214 comprises a preferably closed or delimitedreservoir, such as a tank or container, comprising the working medium,and/or is connected or connectable thereto.

Preferably, the analysis device 200 or pressurized gas supply 214comprises an inlet, the working medium in particular being able to bedrawn in and/or conducted in the pressurized gas supply 214 via theinlet

Preferably, the analysis device 200 or pressurized gas supply 214comprises a filter, the filter preferably being integrated in the inletand/or it preferably being possible for the working medium to befiltered by means of the filter and/or it preferably being possible forparticles to be separated from the working medium by means of thefilter.

The filter is preferably designed as a micro filter or as a fineparticulate air filter. Preferably, particles having a particle diameterof more than 10 μm, particularly preferably more than 8 μm or 9 μm, inparticular more than 6 μm or 7 μm, more particularly preferably morethan 4 μm or 5 μm, can be separated by means of the filter, the particlediameter preferably being the maximum or average diameter of therespective particles. This ensures that the channels or lines in thecartridge that convey the working medium do not become contaminated orclogged and/or that no undesired pressure loss occurs.

The analysis device 200 or pressurized gas supply 214 preferablycomprises a connection element 214A, in particular in order topneumatically connect the analysis device 200 and/or pressurized gassupply 214 to the cartridge 100.

FIG. 3 is a schematic view of the proposed analysis system 1 for testingan in particular biological sample P, comprising the analysis device 200for receiving the cartridge 100 and subsequently carrying out the testusing the received cartridge 100, and an operating instrument 400 forthe analysis device 200.

The operating instrument 400 is preferably designed to control theanalysis device 200. Alternatively, or additionally, the operatinginstrument 400 can receive or retrieve information, in particular(measurement) results such as measured values, from the analysis device200. In particular, the operating instrument 400 is a mobile terminaldevice such as a smartphone, a tablet or the like.

The operating instrument 400 is preferably implemented or provided so asto be physically separated from the analysis device 200. The operatinginstrument 400 can preferably be separated and/or disconnected from theanalysis device 200 physically and/or with respect to a data connection.

The operating instrument 400 can preferably be wirelessly connected tothe analysis device 200. A data connection DVA can thus be establishedbetween the analysis device 200 and the operating instrument 400.However, the data connection DVA can in principle also be established inanother manner, for example wired.

It is preferable for the operating instrument 400 to also be operationalwhen separated or disconnected from the analysis device 200, inparticular for carrying out evaluations or for other purposes.Alternatively, or additionally, the analysis device 200 is alsooperational when separated or disconnected from the operating instrument400, in particular for continuing a test.

Particularly preferably, the operating instrument 400 comprises aninterface 430 for establishing data connections DVA, DVB, DVD. Theinterface 430 and/or the operating instrument 400 in particularcomprises what is referred to as an analysis device interface 431 thatis designed to establish the preferably wireless data connection DVA tothe analysis device 200. This can, for example, be a radio interface,WPAN interface, Bluetooth interface and/or a Bluetooth module or thelike.

The interface 210 of the analysis device 200 preferably corresponds tothe interface 430 and/or the analysis device interface 431 of theoperating instrument 400, in particular such that the data connectionDVA between the operating instrument 400 and the analysis device 200 canbe established. The interface 210 of the analysis device 200 and theanalysis device interface 431 preferably support the same datatransmission method and/or radio transmission method or radio standard,in particular WLAN or WPAN methods such as Bluetooth, NFC, Zigbee or thelike.

Particularly preferably, the interface 210 of the analysis device 200and the analysis device interface 431 make possible or facilitate whatis known as an ad-hoc connection. In this case, the data connection DVAis established preferably automatically when the devices, i.e., theoperating instrument 400 and the analysis device 200, are within rangeof one another. In other words, the operating instrument 400 and theanalysis device 200 each comprise a wireless data interface 430, 210,respectively, which are designed to jointly establish an ad-hoc dataconnection between the operating instrument 400 and the analysis device200, preferably such that, when the operating instrument 400 and theanalysis device 200 approach one another in space, the data connectionDVA therebetween is automatically established and is preferablydisplayed by means of the operating instrument 400.

The data connection DVA is preferably a point-to-point connection. Thedata connection DVA connects the analysis device 200 to the operatinginstrument 400 preferably directly and/or without any interposednetworks. It is possible for the operating instrument 400 to establishdata connections DVA to different analysis devices 200 simultaneously orin succession. Alternatively, or additionally, it is possible for oneanalysis device 200 to establish data connections DVA to a plurality ofoperating instruments 400 simultaneously or in succession.

In order to control the test, it is preferable for precisely one dataconnection DVA to be provided between the analysis device 200 to becontrolled and the operating instrument 400 controlling the analysisdevice 200, and/or for control information 510 to be received and/oraccepted or to be acceptable and/or receivable and/or for measurementresults 713 to be transmitted or to be transmittable only via preciselyone data connection DVA between the analysis device 200 to be controlledand the operating instrument 400 controlling the analysis device 200.

The analysis device 200 preferably comprises a receiver 210A for,preferably wirelessly, receiving the control information 510 from theoperating instrument 400. Preferably, the interface 210 comprises thereceiver 210A, via which signals, in particular control information 510,are or can be received from the operating instrument 400.

Alternatively, or additionally, the analysis device 200 and/or theinterface 210 comprises a transmitter 210B, via which data, inparticular results such as measurement results 713 from the sensorapparatus 113, are or can be sent, particularly preferably to theoperating instrument 400.

The interfaces 210, 431 preferably correspond to one another such thatthey support the same data transmission standard and/or radio standard,in particular Bluetooth, WLAN or the like. These interfaces areparticularly preferably interfaces 210, 431 which make possible what isknown as an ad-hoc connection, the data connection DVA preferably beingestablished automatically when the devices, i.e., the operatinginstrument 400 and the analysis device 200, are within range of oneanother.

The analysis system 1 preferably further comprises a database 500 or thedatabase 500 is assigned to the analysis system 1. The database 500 ispreferably an external database 500 that is implemented or provided soas to be physically separated from the operating instrument 400 and/orfrom the analysis device 200. In principle, however, it is notimpossible for the database 500 to be provided or implemented such thatit can be directly linked, in particular to the operating instrument400, or to be provided or implemented by the operating instrument 400.

The operating instrument 400 can access the database 500 via a dataconnection DVD. For this purpose, the operating instrument 400 and/orthe interface 430 can comprise a database interface 432 by means ofwhich the database 500 can be accessed, in particular via a network N.The network N may be the Internet or another data network. It is alsopreferable for the operating instrument 400 to be able to establish thedata connection DVD to the database 500 via a wireless interface, inparticular WLAN, WPAN, mobile communications or the like. However, inprinciple, other solutions are also possible here.

Particularly preferably, the operating instrument 400 comprisesdifferent interfaces 430 that are independent of one another forestablishing data connections DVA, DVD to the analysis device 200 and tothe database 500, the analysis device 200 (as a peripheral device of theoperating instrument 400) being designed to communicate exclusively withor via the operating instrument 400.

The analysis system 1, in particular the database 500, preferablycomprises control information 510 by means of which the analysis device200 can be controlled in order to carry out a test.

The control information 510 preferably defines the actuation of theactuators of the analysis device 200 in a particular manner, such thatthe sample P is tested in the cartridge 100. In particular, actuatorsfor carrying out the test can be or are controlled using the controlinformation 510 such that said actuators act on the cartridge 100 and/orthe sample P. These actuators are in particular the pump drive 202and/or one or more temperature-control apparatus 204 and/or one or morevalve actuators 205. The control information 510 preferably comprisesparameters and/or instructions for carrying out one or more steps of themethod for testing the sample P explained above.

Preferably, the analysis system 1 comprises calibration information 520that can be stored in the database 500 and/or can be retrieved from thedatabase 500. The calibration information 520 is preferably capable ofinfluencing the test of the sample P, in particular depending on thespecific cartridge 100, on a cartridge batch of the specific cartridge100 and/or on the specific test.

The calibration information 520 is in particular default or basicsettings, parameters and/or threshold values for sensors such as thesensor apparatus 113 of the cartridge 100, for one or more of thesensor(s) 206A-H of the analysis device 200 and/or for one or more ofthe actuators.

Calibration information 520 can be used in addition to controlinformation 510 for carrying out the test, the calibration information520 preferably influencing or specifying the control information 510.The calibration information 520 can be or can form the controlinformation 510 or a part of the control information 510, even if thisis not explicitly mentioned in the following.

The analysis device 200 can be calibrated and/or configured bycalibration information 520 that can form part of the controlinformation 510 or can be provided separately. For this purpose, thecalibration information 520 can be determined, retrieved and/ortransmitted to the analysis device 200 by means of the operatinginstrument 400.

In one example, fluid sensor calibration information 521 is providedwhich influences setting and/or evaluation of the fluid sensor 206A. Thefluid sensor calibration information 521 is preferably dependent on thetest to be carried out, the phase of the test and/or expected effects ofa content change in a sensor portion 116 during the test sequence,and/or contains various specifications which are dependent thereon.

Alternatively, or additionally, tilt sensor calibration information 524can be provided, preferably comprising one or more threshold values 525,in particular a start threshold value 526 for blocking the start of atest if said threshold value is exceeded, and/or an interruptionthreshold value 527 for interrupting the test and/or for processingerrors if said threshold is exceeded.

Alternatively, or additionally, sensor arrangement calibrationinformation 528 can be provided, by means of which properties of thesensor arrangement or sensor apparatus 113 are or can be set. Inparticular, it is provided that the sensor arrangement calibrationinformation 528 is transmitted or can be transmitted to the sensorarrangement or sensor apparatus 113 by the analysis device 200, and thatthe sensor arrangement or sensor apparatus 113 carries out or isdesigned to carry out a measurement taking into account the sensorarrangement calibration information 528.

The proposed analysis system 1 preferably comprises evaluationinformation 530 which is stored in the database 500 and/or isretrievable or can be retrieved from the database 500. The evaluationinformation 530 is preferably designed to be able to interpretmeasurement results 713 that originate from the cartridge 100, inparticular from the sensor apparatus 113.

The control information 510 and/or the evaluation information 530particularly preferably comprises instructions, preferably in the formof an algorithm and/or for controlling a process on or using a processoror controller. The instructions preferably form a module that can be oris implemented by the analysis device 200 and/or the operatinginstrument 400, as a result of which the behavior of the analysis device200 and/or the operating instrument 400 can be or is changed.

The instructions are in particular commands, machine code, pre-compiledsource code or source code. The instructions preferably form amodule-type software component, in particular a plugin. The instructionscan be designed to form and/or to replace a module of the operatinginstrument 400 and/or of the analysis device 200. For this purpose, thecontrol information 510 and/or the evaluation information 530 cancomprise a (software) interface for coupling or implementation by thecontrol apparatus 207 and/or an evaluation module 440 of the operatinginstrument 400.

The control information 510 particularly preferably comprises or forms amodule of the control apparatus 207 that can be exchanged, preferably interms of software. This module preferably contains instructions such aslogic commands, loops and the like for controlling the test, inparticular in the form of a computer program or computer program productto be executed by the analysis device 200 and/or the control apparatus207. The control information 510 can be or form, in particular as aplugin, an exchangeable part of the control apparatus 207.

An evaluation module 440 is preferably formed by the operatinginstrument 400 or the operating instrument 400 comprises the evaluationmodule 440. By means of the evaluation module 440, measurement results713 read out from the sensor apparatus 113 are evaluated preferablyusing the evaluation information 530 retrieved from the database 500and/or the evaluation module 440 is designed for this purpose.

The evaluation information 530 particularly preferably comprises orforms a module of the evaluation apparatus 440 that can be exchanged,preferably in terms of software. This module preferably containsinstructions such as logic commands, loops and the like for controllingthe evaluation of measurement results 713, in particular in the form ofa computer program or computer program product to be executed by theoperating instrument 400 and/or the evaluation module 440. Theevaluation information 530 can be or form, in particular as a plugin, anexchangeable part of the evaluation module 440. The computer programproduct preferably is a non-transitory computer-readable media.

Alternatively, or additionally, the instructions can comprise parametersfor configuring the control apparatus 207 and/or the evaluation module440. These parameters are preferably provided in addition to theinstructions, for example for the analysis device 200 in the form of orcomprising the calibration information 520. Alternatively, the controlinformation 510 and/or evaluation information 530 can however alsomerely comprise parameters and/or other information for the controland/or evaluation.

The database 500 preferably comprises a results memory 550 in whichresults can be stored and/or saved.

Within the meaning of the present invention, the term “database” shouldpreferably be understood in a broad sense and also incorporatesmulti-part databases in particular. Therefore, in principle, thedatabase 500 can be provided in different physical units or at differentlocations and/or can be composed of a plurality of sub-databases.

The operating instrument 400 can preferably be separated and/ordisconnected from the analysis device 200 with respect to a dataconnection and/or physically. For this purpose, the analysis device 200can initially be connected to the operating instrument 400 by the dataconnection DVA being established.

In order to control the test and/or the analysis device 200, theoperating instrument 400 can retrieve control information 510 from thedatabase 500 and transmit said information to the analysis device 200 inunaltered or altered form.

The operating instrument 400 is preferably designed to evaluatemeasurement results 713 which can preferably be generated by the sensorapparatus 113 of the cartridge 100 while the sample P is being tested.For this purpose, it is provided that measurement results 713, which canoriginate from a sensor apparatus 113 of the cartridge 100 and/or whichcan be transmitted from the analysis device 200 to the operatinginstrument 400, are or can be evaluated in the operating instrument 400.For this purpose, the operating instrument 400 can retrieve or receivethe evaluation information 530 from the database 500 and, using thisevaluation information 530, evaluate the measurement results 713, inparticular in the evaluation module 440 of the operating instrument 400.

The operating instrument 400 preferably comprises a memory 450. Thememory 450 can be used to store, at least temporarily, controlinformation 510, calibration information 520 and/or evaluationinformation 530, or the operating instrument 400 and the memory 450 canbe designed for this purpose. Alternatively, or additionally, evaluationresults 740, that have been or can be generated from the measurementresults 713 by means of the operating instrument 400, can be stored inthe memory 450.

In one example, the operating instrument 400 comprises an outputapparatus 410, preferably an in particular touch-sensitive screen ordisplay 411 and/or a speaker 412. Alternatively, or additionally, theoperating instrument 400 comprises an input apparatus 420, in particulara camera 421, a touchpad 422, a microphone 423 and/or a keyboard 424.

The operating instrument 400 is preferably designed to display anoperating interface or a user interface via the output apparatus 410, inparticular the screen or display 411, or to provide in another wayoperating elements for controlling the test and/or the analysis device200, and/or to output a status or other information relating to the testAlternatively, or additionally, commands can be received via the inputapparatus 420, by means of which the operating instrument 400 starts,configures and/or controls the test of the sample P in a mannercorresponding to the commands.

Preferably, the transmission of commands and/or information to theanalysis device 200 is triggered via the input apparatus 420 or can betriggered by the input apparatus 420.

In particular, transmission of the control information 510 from theoperating instrument 400 to the analysis device 200 can be initiated orcontrolled via the input apparatus 420. Alternatively, or additionally,the analysis device 200 can be controlled in order to receive thecartridge 100 and/or to start the test, preferably using the controlinformation 510 and/or a command received via the input apparatus 420.The operating instrument 400 is therefore preferably designed totransmit to the analysis device 200 control information 510 forreceiving or ejecting the cartridge 100. In this case, a cartridge 100can in particular be inserted only when the operating instrument 400 isconnected to the analysis device 200, whereupon the operating instrument400 can verify the cartridge 100 and can eject said cartridge or block atest if an error, such as incompatibility, is detected.

Alternatively, or additionally, the operating instrument 400 is designedto transmit control information 510 for starting the test to theanalysis device 200. The test is thus preferably started only by acommand originating from the operating instrument 400. The analysisdevice 200 itself preferably does not comprise a user interface forgenerating a start command or for causing the test to start This task ispreferably reserved for the operating instrument 400.

The cartridge 100 preferably comprises at least one cartridge identifier100C which corresponds to the cartridge 100 and/or to a batch with whichthe cartridge 100 is associated.

The cartridge identifier 100C is in particular a piece of informationthat is specific to the relevant cartridge 100, is in particular uniqueand/or is designed to uniquely identify the cartridge 100, such as anidentification code which is assigned to the relevant cartridge 100 andmakes it possible for said cartridge to be identified in a preferablyunique manner.

Alternatively, or additionally, the cartridge identifier 100C makes itpossible to assign the cartridge 100 to a production cycle and/or to abatch of particular cartridges 100. A batch is preferably characterizedin that cartridges 100 are produced in the same continuous productioncycle and/or are produced having the same components, in particularhaving the same sensor apparatus 113 and/or the same reagents and thelike. There is preferably a plurality of batches which can differ fromone another with regard to production periods, batches of startingmaterials used and the like, for example.

The cartridge identifier 100C can be stored and/or saved in a memorymeans 100D of the cartridge 100. The memory means 100D can be a barcode124, an NFC tag and/or a memory which is provided in the sensorapparatus 113, is connected to the sensor apparatus 113 or is assignedto the sensor apparatus 113, or another apparatus for storing code orthe like.

The cartridge identifiers 100C are preferably assigned to the respectivecartridges 100. In particular, the cartridge identifier 100C is formedby the cartridge 100, connected thereto and/or arranged thereon.

The analysis system 1 can comprise one or a plurality of cartridges 100which can each preferably be distinguished from one another by means ofat least one cartridge identifier 100C and/or which are assigned to abatch.

Another aspect of the present invention, which can also be implementedindependently, relates to a cartridge 100 having at least two cartridgeidentifiers 100C that each correspond to the cartridge 100. Thecartridge identifiers 100C can preferably be read out by differentread-out methods, in particular optically, by radio, by a wiredconnection or the like.

The respective cartridges 100 can comprise two different memory means100D having the same or corresponding cartridge identifiers 100C. Thememory means 100D are preferably independent of one another and/orseparated from one another physically. The memory means 100D canpreferably be read out in different ways, in particular electronicallyand/or by an electronic connection on the one hand, and wirelessly, inparticular optically and/or by radio on the other hand.

In the example shown, corresponding cartridge identifiers 100C arestored, saved or recorded both in a memory that can be read outelectronically, in particular of the sensor apparatus 113, and in amemory that can be read out wirelessly, by radio or optically, inparticular the barcode 124. This makes it possible for the cartridgeidentifier 100C or the cartridge identifiers 100C corresponding to thesame cartridge 100 to be read out in different ways.

This advantageously makes it possible to retrieve control information510, calibration information 520 and/or evaluation information 530 fromthe database 500 independently, disconnected or separately from theanalysis device 200, preferably by optically reading out the cartridgeidentifier 100C from the cartridge 100. Alternatively or additionally, amemory means 100D of the cartridge 100 that can be read outelectronically makes it possible for the cartridge identifier 100C to beread out without there being an optical connection to or visual contactwith the cartridge 100, for example when said cartridge is inserted intothe analysis device 200.

The at least two cartridge identifiers 100C can be the same or, in oneaspect of the present invention, which can also be implementedindependently, said cartridge identifiers 100C can be different Inparticular, it is possible and preferable for a (first) cartridgeidentifier 100C to be individual or unique to the cartridge 100, i.e.,designed to uniquely identify the cartridge 100. A (different or second)cartridge identifier 100C is preferably designed to assign the cartridge100 to a batch of cartridges 100. The at least two cartridge identifiers100C preferably correspond to one another. In particular, the cartridgeidentifier 100C corresponding to the batch and/or the batch can beidentified using the cartridge identifier 100C that uniquely identifiesthe cartridge 100. Preferably, both cartridge identifiers 100C are readout and used, in particular in order to determine and/or retrievecontrol information 510 and/or evaluation information 530 on the onehand and in order to verify said information on the other hand.

The respective cartridges 100 are preferably identified at least twiceor a cartridge identifier 100C is read out and used at least twice,namely preferably once directly by the operating instrument 400 in orderto retrieve control information 510 and/or calibration information 520and/or evaluation information 530 and a second time by means of or viathe analysis device 200 in order to ensure that the testis carried outusing control information 510, calibration information 520 and/orevaluation information 530 that corresponds to the cartridge 100 and/orin order to ensure and/or verify that the control information 510,calibration information 520 and/or evaluation information 530corresponds to the cartridge 100.

FIG. 4 shows a schematic sequence of a preferred method for testingand/or evaluating by means of the proposed analysis system 1, inparticular in a manner which is dependent on the individual cartridge100. The following aspects and/or method steps can also be implementedand can be advantageous individually or in different combinations, thedescribed order being preferred, but not obligatory, and it beingpossible for steps to be omitted or added or carried out independently.

As explained above, at least one cartridge identifier 100C correspondsto the (respective) cartridge 100. This cartridge identifier 100C ispreferably stored in a memory means 100D, in particular the barcode 124and/or a memory cell of the sensor apparatus 113, on the cartridge 100.However, in principle, other storage options are possible here or thereis the option of providing other memory means 100D. For example, amemory means 100D assigned to the cartridge 100 can be arranged on thepackaging of the cartridge 100 or can form part of said packaging.

Preferably, the cartridge 100, in particular the sensor apparatus 113,is electrically contacted by the analysis device 200. This is preferablyachieved by one or more contact elements 203A, as shown in FIG. 1 by wayof example.

If the cartridge identifier 100C is stored in the sensor apparatus 113or is assigned thereto, said cartridge identifier 100C can be read outby the analysis device 200 via a data connection DVC between thecartridge 100 and the analysis device 200 that can be created by meansof the contact elements 203A. This is symbolized by the arrow 601, whichrepresents the data transmission from the cartridge 100 to the analysisdevice 200. The cartridge identifier 100C stored in the sensor apparatus113 and/or assigned to the sensor apparatus 113 identifies the cartridge100 preferably uniquely or on a one-to-one basis.

The cartridge identifier 100C read out from the cartridge 100 by theanalysis device 200 can be transmitted to the operating instrument 400via the data connection DVA between the analysis device 200 and theoperating instrument 400, as indicated in FIG. 4 by the arrow 602, whichrepresents the data transmission between the analysis device 200 and theoperating instrument 400. In addition to the cartridge identifier 100C,a device identifier 200C can optionally also be transmitted from theanalysis device 200 to the operating instrument 400. The deviceidentifier 200C preferably corresponds to the specific analysis device200 and/or makes it possible for the analysis device 200 to beidentified.

In an alternative, which can also be carried out additionally, thecartridge identifier 100C is or can be determined directly by theoperating instrument 400. Particularly preferably, this is achievedoptically and/or using the camera 421 of the operating instrument 400,preferably by reading in a code, in particular the barcode 124. It ishowever also possible for the cartridge identifier 100C to be directlyand/or wirelessly determined from the relevant cartridge 100 by theoperating instrument 400 in some other way, for example by radio, inparticular by reading out an RFID tag which is optionally assigned tothe cartridge 100 or arranged on the cartridge 100, or an NFC memoryapparatus or the like which is assigned to the cartridge 100, isarranged on the cartridge 100 or forms part of the cartridge 100 in someother way.

As a result, the cartridge identifier 100C is therefore particularlypreferably transmitted to the operating instrument 400 either directlyby the operating instrument 400 reading out the memory means 100D of thecartridge 100, or indirectly by data being correspondingly transferredvia the analysis device 200, and the operating instrument 400 therebyreceives or determines the cartridge identifier 100C.

In one aspect of the present invention, which can also be implementedindependently, the operating instrument 400 receives or determinesinformation, which is preferably cartridge-specific and/orcartridge-batch-specific, by means of the cartridge identifier 100C, orthe operating instrument 400 is designed for this purpose.

The operating instrument 400 retrieves or is designed to retrieve,preferably automatically, the control information 510 for controllingthe analysis device 200 in order to carry out the test supported by thecartridge 100 and/or analysis information 530 for evaluating measurementresults 713 determined during the test, by reading out the cartridgeidentifier 100C of the cartridge 100 or after said cartridge identifier100C has been read out.

In particular, it is provided that the operating instrument 400 receivesor retrieves control information 510 on the basis of the cartridgeidentifier 100C, which information is specific to the cartridge 100, thebatch thereof and/or specific for carrying out the test using thecartridge 100. Particularly preferably, the control information 510 isretrieved from the database 500 or can be retrieved from the database500.

Preferably, the cartridge identifier 100C is transmitted to the database500, as indicated in FIG. 4 by the arrow 603, which corresponds to thedata transmission from the operating instrument 400 to the database 500.

The database 500 can send back control information 510 corresponding tothe cartridge 100 and/or to the cartridge identifier 100C, i.e.,transmit said information to the operating instrument 400, as indicatedin FIG. 4 by the arrow 604, which represents the data transmissionbetween the database 500 and the operating instrument 400.

Alternatively, or additionally, calibration information 520 and/orevaluation information 530 can also be transmitted to the operatinginstrument 400 in a corresponding manner from the database 500 to theoperating instrument 400 or is or can be retrieved from the database 500by the operating instrument 400.

In one variant, the information can also be retrieved without thecartridge identifier 100C being transmitted to the database 500. In avariant of this kind, control information 510, calibration information520 and/or evaluation information 530 which is available to theoperating instrument 400 and, for example, has been previously retrievedand/or temporarily stored in the operating instrument 400, can beidentified by means of the operating instrument 400 on the basis of thecartridge identifier 100C and can be selected for subsequent use.

In another variant, which can be combined with the two previous methodsfor determining and/or retrieving the control information 510,calibration information 520 and/or evaluation information 530, theinformation is selected and/or retrieved in addition by using and/ortransmitting a device identifier 200C for identifying the analysisdevice 200 and/or an operating instrument identifier 400C foridentifying the operating instrument 400. This makes it possible for thecontrol information 510, calibration information 520 and/or evaluationinformation 530 to be specific to or compatible with the analysis device200 and/or the operating instrument 400 and for said information to beselected, transmitted, retrieved and/or sent back in a manner in whichit is specific to or compatible with the analysis device 200 and/or theoperating instrument 400.

Preferably, control information 510 is retrieved or determined thatcorresponds to both the cartridge 100 and the analysis device 200,particularly preferably to the combination of the cartridge 100 and theanalysis device 200. As a result, the test can be carried out in amanner which is specific to both the cartridge 100 and the analysisdevice 200, and this contributes to making tests highly reproducible andreliable.

In one aspect of the present invention, which can also be implementedindependently, the cartridge identifier 100C, which preferablycorresponds only to the batch with which the cartridge 100 isassociated, is first determined by the operating instrument 400, inparticular is or can be read out from the cartridge 100 directly by theoperating instrument 400.

Using the cartridge identifier 100C, the control information 510 and/orevaluation information 530 is retrieved, in particular by means of theoperating instrument 400. The retrieved control information 510 and/orevaluation information 530 is preferably stored temporarily in theoperating instrument 400.

The control information 510 is transmitted by the operating instrument400 preferably to the analysis device 200 or the operating instrument400 is designed for this purpose. This is indicated in FIG. 4 by thearrow 605, which corresponds to data transmission from the operatinginstrument 400 to the analysis device 200.

Optionally, calibration information 520 can also be transmitted from theoperating instrument 400 to the analysis device 200. Alternatively, oradditionally, the operating instrument 400 can modify the controlinformation 510, in particular taking into account the calibrationinformation 520. The control information 510 can however also alreadycomprise or incorporate the calibration information 520. It is thereforenot obligatory for the calibration information 520 to be transmitted tothe analysis device 200.

Preferably, transmission only takes place if the cartridge 100, thecontrol information 510, and the assignment, association and/orcompatibility thereof have been verified. This ensures that the controlinformation 510 to be transmitted corresponds to the cartridge 100 whichis intended to be used to carry out the test This is provided for inparticular if the control information 510 and/or evaluation information530 has been previously retrieved by the operating instrument 400 and/orstored temporarily in the operating instrument 400.

Verification is achieved particularly preferably by a/the cartridgeidentifier 100C. In particular, for verification, a cartridge identifier100C different from the cartridge identifier for retrieving the controlinformation 510 and/or evaluation information 530 is used, and/or acartridge identifier 100C that is read out from another memory means100D of the cartridge 100 is used.

The cartridge identifier 100D provided for verification is preferablyread out by means of or via the analysis device 200 and/or transmittedto the operating instrument 400. This takes place if the cartridge 100is in direct contact with the analysis device 200 for carrying out thetest, i.e., if the cartridge 100 is in particular loaded or insertedinto the analysis device 200. This ensures that the cartridge 100 whichis intended to be used to carry out the testis determined. Verificationby means of the cartridge identifier 100C of the cartridge 100 thereforemakes it possible to ensure that the test is carried out using thecontrol information 510 that corresponds to the cartridge 100.

Verification can be achieved by checking that the cartridge identifier100D provided for verification is assigned to the control information510 and/or by checking that the cartridge identifier 100C provided forverification is assigned to the cartridge identifier 100C used fordetermining the control information 510. In this respect, it can bechecked whether the cartridge identifier 100C provided for verificationcorresponds to the batch of cartridges 100 to which the controlinformation 510 corresponds. This can be achieved by an assignment,allocation or mapping, such as a table or database, and/or byverification means which are assigned to or form part of the controlinformation 510. For this purpose, the control information 510 cancomprise corresponding assignment means, for example informationrelating to cartridge identifier groups. Verification can be carried outby these assignment means.

Other retrieved information, in particular the evaluation information530, can be verified in a corresponding manner.

The control information 510 can be received by the analysis device 200and used for controlling the test Alternatively, or additionally, thecontrol information 510 can also be verified in the analysis device 200.

After the control information 510 has been transmitted, the test isstarted, preferably in a manner controlled by the operating instrument400.

In FIG. 4, the testing process on the cartridge 100 by means of theanalysis device 200 is indicated by the arrow 606.

According to one aspect of the present invention, which can also beimplemented independently, the analysis device 200 is designed to carryout the test using the transmitted control information 510 andindependently and/or separately and/or disconnected from the operatinginstrument 400 and/or the test is carried out independently and/orseparately and/or disconnected from the operating instrument 400.

Particularly preferably, the test is carried out independently and/orseparately from the operating instrument 400. For this purpose, theanalysis device 200 is preferably designed to carry out or continue thetest using the transmitted control information 510 and independentlyand/or separately and/or disconnected from the operating instrument 400and/or when the data connection DVA is disconnected, terminated orbroken.

This makes it possible for example to transmit the control information510 to the analysis device 200 by means of the operating instrument 400,to start the test process, and to subsequently disconnect, terminate orbreak the data connection DVA between the analysis device 200 and theoperating instrument 400, such that the analysis device 200 carries outor can carry out the test self-actingly, automatically and/orautonomously of and independently from the operating instrument 400.Therefore, while the testis underway, a user together with the operatinginstrument 400 can move away from the analysis device 200 and/or can usethe operating instrument 400 for other purposes.

In order to carry out the test, the analysis device 200 preferably actson the cartridge 100 such that the sample P is prepared, conveyed and/oranalyzed inside the cartridge 100, or the analysis device 200 isdesigned for this purpose. Preferably, the test is or can be controlledby the control apparatus 207 of the analysis device 200.

In order to carry out the test, the analysis device 200 preferablyreceives the control information 510 and, preferably, the calibrationinformation 520, particularly preferably via the operating instrument400 in each case. For this purpose, the operating instrument 400 ispreferably designed to transmit, and the analysis device 200 is designedto receive, the control information 510 and, preferably, the calibrationinformation 520.

Using the control information 510, the control apparatus 207 controlsapparatus and/or actuators of the analysis device 200 such that saidapparatus and/or actuators act on the cartridge 100, or the controlapparatus 207 is designed for this purpose.

The actuators are in particular the pump drive 202, thetemperature-control apparatus 204 and/or the (valve) actuators 205. Bymeans of the actuators, the sample P can be conveyed within the fluidsystem 103 of the cartridge 100 and/or the temperature of the sample Pcan be changed and/or the sample P can be mixed with reagents and/orprepared and/or fed to the sensor apparatus 113 in order to ultimatelydetermine, by means of the sensor apparatus 113, measurement results 713that correspond to the sample P.

The sample P is preferably conveyed inside the cartridge 100 to thesensor apparatus 113 in a manner specified by the control information510 and/or the analysis device 200 is designed to do this, preferablytogether with the cartridge 100.

Valves 115A, 115B of the cartridge 100 are preferably opened or closedin a manner specified by the control information 510 and/or the analysisdevice 200 is designed to do this, preferably together with thecartridge 100.

One or more temperature-control apparatus 204 of the analysis device 200are preferably controlled such that the sample P and/or sensor apparatus113 are temperature-controlled in a manner specified by the controlinformation 510 and/or the analysis device 200 is designed to do this,preferably together with the cartridge 100.

Control on the basis of the control information 510 and, preferably, ofthe calibration information 520 is preferably carried out, as explainedin connection with FIGS. 1 and 2, in particular so as to carry out anucleic-acid assay for detecting a nucleic-acid sequence and/or aprotein assay for detecting a protein. The control information 510 istherefore preferably designed to, the control information 510 inparticular comprising instructions and/or parameters, in order to carryout a nucleic-acid assay for detecting a nucleic-acid sequence and/or aprotein assay for detecting a protein. However, other assays are alsopossible.

The control information 510 preferably comprises valve controlinformation 510A for actuating one or more valve actuators 205 in orderto open and/or close valves on the cartridge 100.

Alternatively, or additionally, the control information 510 comprisespump drive control information 510B for controlling the pump drive 202,which can act, mechanically or otherwise, on the pump apparatus 112 ofthe cartridge 100 in order to convey fluid, in particular the sample P,through the fluid system 103 of the cartridge 100.

Alternatively, or additionally, the control information 510 comprisestemperature-control apparatus control information 510C which specifies atemperature or a temperature curve or temperature profile of or for oneor more temperature-control apparatus 204 of the analysis device 200, asa result of which the sample P or another substance contained in thefluid system 103 of the cartridge 100 can be temperature-controlled, inparticular in order to carry out a PCR and/or hybridization.

Alternatively, or additionally, the control information 510 comprisesexecution information 511 for executing the test, in particular thesequence for controlling different actuators. The execution information511 can also be separate from the control information 510, can be storedin the database 500 and/or can be transmitted to the analysis device 200and/or the operating instrument 400.

Execution information 511 includes in particular delay information 511A,looping information 511B for repeating certain steps and/or conditioninformation 511C for defining conditions, in particular thresholdvalues, for triggering further steps or events.

The control information 510 can be in the form of a control file. Thecontrol information 510 preferably contains or can be represented as acommand sequence which defines the execution of the test, in particularin a sequential or procedural manner. The analysis device 200 preferablycomprises an interpreter for the control information 510.

The analysis device 200 and/or the control apparatus 207 preferablycomprises a memory 207A in which the control information 510 is storedand/or temporarily stored or in which said information can be stored. Inparticular, it is provided that the analysis device 200 receives thecontrol information 510 and, optionally, calibration information 520 andsaves said information in the memory 207A. This makes it possible forthe control apparatus 207 to control the analysis device 200 and/oractuators of the analysis device 200 independently and/or separatelyand/or disconnected from the operating instrument 400 in order to carryout or continue the test of the sample P.

The control apparatus 207 preferably controls and/or feedback controlsand/or is designed to control and/or feedback control apparatus of theanalysis device 200 in order to carry out the test.

The control apparatus 207 preferably comprises an actuator interface207B by means of which one or more of the actuators can be controlled.In particular, the actuator interface 207B makes it possible to supplypower to and/or to specify a target value for one or more of theactuators. This makes it possible to specify a target temperature valueand/or a target temperature profile or curve for one or more of thetemperature-control apparatus 204 by means of the actuator interface207B. Alternatively, or additionally, the pump drive 202 can becontrolled.

The pump drive 202 preferably comprises a stepper motor, as a driveelement, and the actuator interface 207B preferably comprises acorresponding stepper motor controller. Owing to this combination, fluidcan be conveyed in the fluid system 103 of the cartridge 100 in a veryaccurate manner. In addition, via the actuator interface 207B, theanalysis device 200 and/or the control apparatus 207 can activate and/orsupply power to one or more of the valve actuators 205, such that valves115A, 115B located on the cartridge 100 can be opened and/or closed.

Alternatively or additionally, the analysis device 200, in particularthe control apparatus 207, comprises a read-out module 207C for readingout measurement results 713 from the sensor apparatus 113. The read-outmodule 207C can be designed to digitalize measurement results 713determined in the sensor apparatus 113 and to store and/or transmit saidresults in the form of a code or data set. In some cases, at least withregard to the digitalization of the measurement results, the read-outmodule 207C can also be located in the cartridge 100 or in the sensorapparatus 113, and/or the read-out module 207C can read out measurementresults 713 digitalized by the sensor apparatus 113.

Alternatively, or additionally, the analysis device 200 and/or thecontrol apparatus 207 can comprise an error module 207D for identifyingerrors. In particular, the error module 207D is designed to detecterrors in the execution of the test. Alternatively, or additionally, theerror module 207D can detect and document errors in boundary conditions,for example, a temperature, inclination or the like, and/or control theanalysis device 200 according to and/or taking into account the errordetection.

The analysis system 1, the cartridge 100 and/or the analysis device 200is/are preferably designed to carry out the proposed method and/or themethod is preferably controlled by means of the control information 510,taking into account the control information 510 or in a manner specifiedby the control information 510. However, the method described below canalso be modified and the invention can also be used and be advantageousfor other methods for testing an in particular biological sample.

Within the context of the method, a sample P having at least one analyteA on the basis of a fluid or a liquid from the human or animal body, inparticular blood, saliva or urine, is usually first introduced into thereceiving cavity 104 via the connection 104A, in order to detectdiseases and/or pathogens, it being possible for the sample P to bepretreated, in particular filtered.

Once the sample P has been received, the receiving cavity 104 and/or theconnection 104A thereof is fluidically closed, in particular in aliquid-tight and/or gas-tight manner.

Preferably, the cartridge 100 together with the sample P is then linkedor connected to the analysis device 200, in particular is inserted orslid into the analysis device 200.

The method sequence, in particular the flow and conveying of the fluids,the mixing and the like, is controlled by the analysis device 200 or thecontrol apparatus 207, in particular by accordingly activating andactuating the pump drive 202 or the pump apparatus 112 and/or the valveactuators 205 or valves 115A, 115B.

During the nucleic-acid assay, a desired volume of the sample P that ismixed and/or pretreated in the mixing cavity 107 is subsequentlypreferably fed to one or more reaction cavities 109A-C, particularlypreferably via (respectively) one of the upstream, optional intermediatecavities 106A to 106C and/or with different reagents or primers, in thiscase dry reagents S4 to S6, being added or dissolved.

In the reaction cavities 109A-C, the amplification reactions or PCRs arecarried out to copy/amplify the analytes A. This is carried out inparticular by means of the assigned, preferably common, reactiontemperature-control apparatus(es) 204A and/or preferably simultaneouslyfor all the reaction cavities 109A-C, i.e., in particular using the samecycles and/or temperature (curves/profiles).

During the nucleic-acid assay, a label is in particular produceddirectly and/or during the amplification reaction(s) (in each case)and/or is attached to the analytes A and/or amplification products. Thisis in particular achieved by using corresponding, preferablybiotinylated, primers. However, the label can also be produced and/orbonded to the analytes A and/or amplification products separately orlater, optionally also only in a sensor compartment of the sensorapparatus 113 and/or after hybridization. In particular, during theprotein assay, a label is only bonded to analytes A after hybridizationof the analytes A to the capture molecules.

The label is used in particular for detecting bonded analytes A and/oramplification products. In particular, the label can be detected or thelabel can be identified in a detection process, as explained in greaterdetail in the following.

After carrying out the amplification reaction(s), corresponding fluidvolumes and/or amplification products are conducted out of the reactioncavities 109A-C in succession to the sensor arrangement, in particularthe sensor apparatus 113 and/or the sensor compartment, in particularvia a group-specific and/or separate intermediate cavity 106E, 106F or106G (respectively) and/or via the optional (common) intermediatetemperature-control cavity 110.

After the sample P and/or the analytes A and/or amplification productsare fed to the sensor apparatus 113, the analytes A and/or amplificationproducts are hybridized to the capture molecules, preferably by(actively) temperature-controlling, in particular heating, the sensorarrangement or sensor apparatus 113, in particular by means of thesensor temperature-control apparatus 204C.

When carrying out the protein assay, the sample P or the analytes Ais/are preferably fed directly from the mixing cavity 107 to the sensorarrangement or sensor apparatus 113 and/or is/are guided past theintermediate cavity/cavities 106A-G, reaction cavity/cavities 109A-Cand/or the intermediate temperature-control cavity 110 via the bypass114A.

Once the sample P, analytes A and/or amplification products arehybridized and/or bonded to the capture molecules, detection follows, inparticular by means of the preferably provided label, or in anothermanner.

In the following, a particularly preferred variant of the detection isdescribed in greater detail, specifically electrochemical detection, butother types of detection, for example optical detection, capacitivedetection or the like, may also be carried out.

Following the (respective) bondings/hybridizations, preferably anoptional washing process takes place and/or additional reagents orliquids, in particular from the storage cavities 108B to 108E, areoptionally fed in.

Subsequently and/or after the washing process, in accordance with apreferred variant of the method, detection of the analytes A and/oramplification products bonded to the capture molecules takes place.

If the bonded analytes A or amplification products are still not markedor provided with a label, in particular during the protein assay, thelabels are then fed to the sensor arrangement or the sensor compartment,preferably from the storage cavity 108E. Optionally, there is thenanother washing process.

In order to detect the analytes A or amplification products bonded tothe capture molecules, a reagent F4 and/or detector molecules, inparticular alkaline phosphatase/streptavidin, is/are fed to the sensorapparatus 113, preferably from the storage cavity 108D.

Within the meaning of the present invention, the term “detectormolecules” is preferably understood to mean molecules that bondspecifically to the marker or label of the (bonded) analytes A oramplification products and thus allow the detection thereof

In particular, the detector molecules may be enzyme conjugates and/orimmunoconjugates, which bond specifically to the marker or label, inparticular biotin, and comprise a reporter enzyme for converting asubstrate.

In the context of the present invention, the detector molecules arepreferably based on streptavidin, which has a high affinity for biotin,and/or alkaline phosphatase, which can convert non-reactive phosphatemonoesters to electrochemically active molecules and phosphate.

Preferably, a detection system is used, where the label is based onbiotin and where the detector molecules are based onstreptavidin/alkaline phosphatase. However, other detector molecules canalso be used.

The reagents F4 or detector molecules can bond to the bonded analytes oramplification products, in particular to the label of the bondedanalytes A or amplification products, particularly preferably to thebiotin marker.

Optionally, subsequently or after the reagents F4 and/or detectormolecules have bonded to the analytes A and/or amplification productsand/or the labels, an (additional) washing process and/or flushing takesplace, preferably by means of the fluid or reagent F3 or wash buffer, inparticular in order to remove unbonded reagents F4 and/or detectormolecules from the sensor apparatus 113.

Preferably, a reagent S8 and/or substrate for the detection, inparticular from the storage cavity 106D, is lastly fed to the sensorarrangement or sensor apparatus 113, preferably together with a fluid orreagent F2 (in particular a buffer), which is suitable for thesubstrate, particularly preferably for dissolving the reagent S8 and/orsubstrate, the fluid or reagent in particular taken from the storagecavity 108B.

Preferably, p-aminophenyl phosphate (pAPP) is used as the substrate.

The substrate preferably reacts on and/or with the bonded analytes A oramplification products and/or detector molecules and/or allows these tobe electrochemically measured.

Preferably, a first or electrochemically active substance is detected inthe sensor apparatus 113 by electrochemical measurement and/or redoxcycling.

The measurement is preferably taken just once and/or for the entiresensor array 113A of the sensor apparatus 113 and/or for all the sensorfields 113B of said sensor array, in particular simultaneously or inparallel. In particular, the bonded analytes A or amplification productsare detected, identified or determined simultaneously or in parallel ina single or common detection process.

However, in principle, it is also possible to measure a plurality ofsample portions in the sensor apparatus 113 or in a plurality of sensorapparatus 113 in succession or separately.

The test results or measurement results 713 are in particularelectrically transmitted to the analysis device 200 or the controlapparatus 207 thereof, preferably by means of the electrical connectionapparatus 203, and are accordingly prepared, analyzed, evaluated,stored, displayed and/or output, in particular by the display apparatus209 and/or interface 210.

After the test has been carried out, the cartridge 100 is disconnectedfrom the analysis device 200 and/or is released or ejected therefrom,and is in particular disposed of

The test results or measurement results 713 that have been determined bymeans of the testing method described above or by means of anothertesting method are transmitted, in particular electrically, to theanalysis device 200 and/or the control apparatus 207 thereof, preferablyby means of the electrical connection apparatus 203. The measurementresults 713 are transmitted from or via the analysis device 200preferably to the operating instrument 400, and are prepared, analyzed,evaluated, stored, displayed and/or output by the operating instrument400.

The measurement result(s) 713 of the sensor apparatus 113 is/arepreferably transmitted from the cartridge 100 to the analysis device 200and/or retrieved by the analysis device 200 from the cartridge 100and/or the sensor apparatus 113. For this purpose, the analysis system 1is preferably designed to transmit the measurement result 713 from thesensor apparatus 113 of the cartridge 100, from the analysis device 200and/or via the analysis device 200 to the operating instrument 400. Thisis indicated in FIG. 4 by the arrow 607, which corresponds to theresults retrieval from the cartridge 100 by the analysis device 200.

In one aspect of the present invention, which can also be implementedindependently, the measurement result(s) 713, i.e., in particular theresult for the test of the sample P using the analysis device 200,is/are preferably transmitted to the operating instrument 400 withoutany prior evaluation or can be transmitted without any prior evaluation.This is indicated in FIG. 4 by the arrow 608, which corresponds to thedata transmission from the analysis device 200 to the operatinginstrument 400.

Transmitting the measurement results 713 without any prior evaluation inthe analysis device 200 makes possible an individual and/or easilyadaptable evaluation outside of the analysis device 200.

Transmission of the measurement result 713 without any prior evaluationcan also be referred to as the transmission of unprocessed measurementresults 713. This should be understood to mean that, although it ispossible to carry out processing in terms of data transmission, asprovided for by transmission protocols, in order to address transmissionerrors or the like, it is not provided that the measurement results 713are interpreted prior to transmission, i.e., the significance ofmeasurement results is not determined or established and, if applicable,conclusions are not made with regard to properties of the sample P. Inthe present case of a biological sample P, this means in particular thatmeasurement results 713 are assigned to the presence of certainsubstances/analytes and/or concentrations and/or diseases or the likenot in the analysis device 200, but rather externally.

The measurement results 713 are preferably evaluated in the operatinginstrument 400 after the operating instrument 400 has received themeasurement results 713 from the analysis device 200 and/or thecartridge 100. In FIG. 4, the evaluation process by means of theoperating instrument 400 is indicated by the arrow 609.

The evaluation of the measurement results 713 by means of the operatinginstrument 400 can also be carried out independently and/or separatelyand/or disconnected from the analysis device 200.

As mentioned previously, the operating instrument 400 can determineand/or retrieve, in particular from the database 500, evaluationinformation 530 on the basis of the cartridge identifier 100C and/or thedevice identifier 200C. The evaluation information 530 is designed orused to evaluate measurement results 713 determined during the test Themeasurement results 713 can be evaluated by the operating instrument 400on the basis of or using said evaluation information 530. For thispurpose, the operating instrument 400 is preferably designed to retrieveand/or receive measurement results 713 from the analysis device 200.

In one aspect of the present invention, which can also be implementedindependently, the operating instrument 400 evaluates or is designed toevaluate the measurement results 713 using the evaluation information530 and independently and/or separately and/or disconnected from theanalysis device 200. It is also possible for the data connection DVAbetween the analysis device 200 and the operating instrument 400 to bedisconnected, terminated or broken after the measurement results 713have been retrieved, and for the evaluation to also be carried outseparately and/or disconnected from the analysis device 200.

In particular, the evaluation information 530 comprises instructions, inparticular an algorithm, in order to compute or calculate with themeasurement results 713 and to assign said measurement results 713 to aphysical variable, value or property. As a result, the measurementresults 713 can be interpreted.

The evaluation information 530 is preferably individual, unique and/orspecific to a specific cartridge 100 or batch of cartridges 100 and/orto a specific analysis device 200 and/or the combination of a specificcartridge 100 and an analysis device 200. Alternatively or additionally,the evaluation information 530 is individual, unique and/or specific toa/the operating instrument 400, in particular an operating system of theoperating instrument 400.

The evaluation information 530 is particularly preferably dependent onthe specific sensor apparatus 113 of the respective cartridges 100 andcan be specific to a specific type of cartridge or a specific batch ofcartridges and/or a specific test or evaluation that can be carried outusing a type of cartridge or a batch of cartridges.

The measurement results 713 can be evaluated by means of the operatinginstrument 400 on the basis of or using said evaluation information 530.

The evaluation information 530 preferably comprises (field) assignmentinformation 531 which, in the case of a sensor apparatus 113 having aplurality of sensor fields 113B, assigns functions and/or properties tothe measurement results 713 that correspond to the respective sensorfields 113B.

Alternatively, or additionally, the evaluation information 530 comprisesinterpretation information 532 which assigns certain properties of thesample P to measurement results 713. This interpretation information maybe threshold values, or the interpretation information 532 comprisesthreshold values or the like.

Preferably, interpretation information 532 is available that relates tothe respective sensor fields 113B and/or to the measurement results 713corresponding thereto, and therefore the interpretation information 532comprises the (field) assignment information 531 or vice versa.

The (field) assignment information 531 is particularly preferablydependent on the specific sensor apparatus 113 of the respectivecartridges 100 and can be specific to a specific type of cartridgeand/or a specific analysis that can be carried out using a type ofcartridge. Alternatively or additionally, the same also applies to theinterpretation information 532.

Different control information 510 and/or calibration information 520and/or evaluation information 530 can be provided for the same cartridge100, in particular when different tests can be carried out using thesame cartridge 100, and the information corresponds to one of the teststhat can be carried out, respectively.

The evaluation information 530 preferably comprises an assignment of themeasurement results 713, which are preferably in the form of a value, anumber, a code or the like, to a physical variable. As a result, themeasurement results 713 can be interpreted.

The (field) assignment information 531 is preferably designed to assigneach of the measurement results 713 from the respective sensor fields113B to a property or a sensor type of the respective sensor fields113B.

As mentioned at the outset, the evaluation information 530 preferablycomprises instructions, which preferably form an algorithm and/or aplugin or module. This evaluation information 530 can form all or partof the evaluation module 440 of the operating instrument 400. For thispurpose, the evaluation information 530 is integrated in the operatinginstrument 400 as a component or a module which defines the behavior ofthe evaluation module 440 and/or of the operating instrument 400.

The operating instrument 400 implements the evaluation information 530preferably by interpreting the instructions using a processor orcontroller of the operating instrument 400. The instructions are inparticular source code, pre-compiled code or machine code for beingexecuted on the operating instrument 400.

The evaluation information 510 is preferably specific to a certain groupof operating instruments 400, in particular specific to a certainoperating system or a group of operating systems.

Depending on the operating instrument identifier 400C for identifying anoperating instrument 400 or group, class or kind of operatinginstruments 400, in particular having the same operating system, it ispossible to provide, make available and/or retrieve different forms ofthe same or different evaluation information 510. In particular, whentransmitting the operating instrument identifier 400C, the database 500sends evaluation information 510 of such kind back to the operatinginstrument 400, that can be processed, compiled, used and/or executed bythe operating instrument 400.

The analysis system 1, in particular the database 500, thereforepreferably comprises different items of evaluation information 530 or isdesigned to generate and/or provide different items of evaluationinformation 530, the different items of evaluation information 530generating or making possible the same or similar functionality ondifferent operating instruments 400. Nevertheless, the evaluationinformation 530 is preferably specific to a cartridge 100 or a batch ofcartridges 100.

As a result, different items of evaluation information 530 arepreferably provided and/or can be retrieved for different cartridges 100or batches of cartridges 100, and said different items of evaluationinformation 530 are each provided and/or can each be retrieved indifferent versions for different operating instruments 400.

The operating instrument 400 preferably outputs or is designed tooutput, by means of the output apparatus 410, the evaluation results 740that are determined, in particular calculated, by evaluating themeasurement results 713 using the evaluation information 530. For thispurpose, the operating instrument 400 can display the evaluation results740 graphically or otherwise, in particular by means of the screen ordisplay 411. Alternatively, or additionally, the operating instrument400 sends or is designed to send the evaluation results 740 to thedatabase 500.

The operating instrument 400 is preferably designed to transmit, to theanalysis device 200, control information 510 for receiving or ejectingthe cartridge 100. Alternatively or additionally, the operatinginstrument 400 is designed to transmit control information 510 forstarting the test to the analysis device 200. Alternatively oradditionally, the operating instrument 400 is designed to retrieveand/or receive measurement results 713 from the analysis device 200.

The operating instrument 400 is preferably designed to receive and/ordisplay an operating status of the analysis device 200.

In particular, the operating instrument 400 comprises a graphical userinterface which is displayed on the screen or display 411. The graphicaluser interface preferably comprises an interface which graphicallysymbolizes the possible controls and/or states of the analysis device200. Alternatively, or additionally, the user interface is designed tocontrol interaction with the database 500 and/or with the analysisdevice 200. For this purpose, the operating instrument 400 can bedesigned so as to be touch-sensitive, in particular via atouch-sensitive screen or display 411. Alternatively, or additionally,the user interface can however also be controlled via the touchpad 422,the microphone 423, the keyboard 424 or some other input apparatus 420.

In one aspect of the present invention, the analysis system 1 comprisesa plurality of cartridges 100 which support the same or different tests.It is therefore possible for there to be a plurality of different typesof cartridge for carrying out different tests and/or for the analysissystem 1 to comprise or support said types of cartridge. It ispreferable for these cartridges 100 to be inserted into the sameanalysis device 200 and/or for the test using the cartridges 100 to becarried out or be able to be carried out by means of the same analysisdevice 200.

In another aspect, the proposed analysis system 1 comprises a pluralityof analysis devices 200. It is preferable that the analysis devices 200can each be coupled to the same operating instrument 400. The sameoperating instrument 400 can thus be connected to different analysisdevices 200, the data connection DVA preferably connecting to or beingestablished to just one of the analysis devices 200 at any one time.Alternatively, the same operating instrument 400 can however also beconnected to a plurality of analysis devices 200 simultaneously. In thiscase, it is preferable for the operating instrument 400 to assist inselecting an analysis device 200 for configuration and/or control. Inparticular, an analysis device 200 can be selected by the operatinginstrument 400 via the input apparatus 420, such that (only) theselected analysis device 200 is subsequently controlled.

The analysis system 1 can comprise or support a plurality of operatinginstruments 400. In particular, a plurality of operating instruments 400can be coupled to the same analysis device 200 alternately, butpreferably not simultaneously. By coupling the analysis device 200 to anoperating instrument 400, the data connection DVA between the analysisdevice 200 and the operating instrument 400 is preferably established,such that control information 510 can be transmitted to the analysisdevice 200 and/or results can be transmitted to the operating instrument400.

The database 500 preferably comprises a plurality of different items ofcontrol information 510 for carrying out tests using the differentcartridges 100 and/or different analysis devices 200. The controlinformation 510 can also be formed in multiple parts. In particular, thecontrol information 510 can comprise parts specific to the cartridge 100and parts specific to the analysis device 200.

The analysis device 200 can preferably be calibrated and/or configuredby calibration information 520 that can form part of the controlinformation 510 or can be provided separately. For this purpose, thecalibration information 520 can be determined, retrieved and/ortransmitted to the analysis device 200 by means of the operatinginstrument 400.

In one example, fluid sensor calibration information 521 is providedwhich influences setting and/or evaluation of the fluid sensor 206A. Thefluid sensor calibration information 521 is preferably dependent on thetest to be carried out.

In another aspect of the present invention, which can also beimplemented independently, a computer program product is provided thatcomprises program code means for carrying out the proposed method. Thecomputer program product is in particular an instruction stored on astorage medium, in particular in the form of a smartphone app or thelike, which is set up to determine and/or receive the cartridgeidentifier 100C. Alternatively or additionally, said instruction isdesigned to transmit the cartridge identifier 100C to the database 500and to subsequently receive control information 510 from the database500. Alternatively, or additionally, said instruction is designed totransmit or forward control information 510 to the analysis device 200.Alternatively, or additionally, said instruction is designed to receive,evaluate and/or interpret measurement results 713, in particular usingretrieved and/or received evaluation information 530.

Evaluating the measurement results 713 preferably comprises assigningmeasurement results 713 corresponding to particular sensor fields 113Bto functions of the respective sensor fields 113B. This can be achievedby using different evaluation methods, threshold values or the like fordifferent sensor fields 113B.

It is possible for sensor fields 113B of the same kind to be evaluatedtogether. In this case, it is preferable that measurement results 713corresponding to sensor fields 113B of the same kind are tested forconsiderable deviations, that measurement results 713 havingconsiderable deviations with respect to other measurement results 713for sensor fields 113B of the same kind are rejected, and that onlysimilar measurement results 713 for sensor fields 113B of the same kindare evaluated.

During evaluation, it is possible to determine measurement results 713for sensor fields 113B of the same kind. Alternatively, or additionally,the measurement results 713, jointly or in a calculated manner, forexample, the average value thereof, can be compared with a thresholdvalue or with a plurality of threshold values, or evaluated in someother way. In this case, the one or more threshold values may be valuesor, alternatively or additionally, specified profile or curveprogressions, specified gradients, maximum values thereof or the like.

By evaluating the measurement results 713, the evaluation result 740 isgenerated, which preferably corresponds to a physical value, variable orproperty of the sample P, preferably directly. For example, theevaluation result 740 represents the presence of certain DNA sequencesand/or RNA sequences and/or proteins, in particular antigens and/orantibodies.

Alternatively, or additionally, the evaluation result 740 can howeveralso be or comprise an interpretation derived from the presence of theDNA sequences and/or RNA sequences and/or proteins, in particularantigens and/or antibodies, in particular information on whether or howlikely it is that a certain disease and/or pathogen, such as a virus,bacterium or the like, is present in the sample P.

The evaluation result 740 is preferably output by the output apparatus410 of the operating instrument 400, or can be output, in particulardisplayed, by the output apparatus 410.

If a disease and/or a pathogen is detected, it can be provided that theoperating instrument 400 automatically outputs or sends a warning and/ormessage.

Measurement results 713 and/or evaluation results 740 are preferablyarchived. Particularly preferably, these results are saved, or savedtemporarily, in the operating instrument 400. Alternatively, oradditionally, these results are saved and/or archived in the database500, in particular in the results memory 550 of the database 500. Forthis purpose, the evaluation results 740 can be transmitted from theoperating instrument 400 to the database 500 via data transmission 610.

Archiving in the database 500 can be temporally offset with respect tothe evaluation results 740 being generated and/or the measurementresults 713 being retrieved or received. This is in particular the casewhen the test or evaluation is carried out without there being a dataconnection DVD between the database 500 and the operating instrument400. In this case, the measurement results 713 and/or evaluation results740 can be transmitted to the database 500 in a temporally offset mannerand/or at a later point in time, as soon the data connection DVD isrestored or can be re-established.

Control information 510 and/or calibration information 520 and/orevaluation information 530 can be retrieved from the database 500separately, disconnected and/or independently from the analysis device200. For this purpose, a data connection DVB between the cartridge 100and the operating instrument 400 is preferably used, for example by theoperating instrument 400 reading in the barcode 124 and determining thecartridge identifier 100C by evaluation. This is also possible when thedata connection DVA between the analysis device 200 and the operatinginstrument 400 is disconnected, terminated or broken.

Furthermore, the operating instrument 400 can also retrieve controlinformation 510, calibration information 520 and/or evaluationinformation 530 from the database 500 independently, disconnected and/orseparately from the cartridge 100 and/or the analysis device 200. It istherefore possible for example for the operating instrument 400 tofirstly determine, read out or receive the cartridge identifier 100C.Retrieval from the database 500 can take place subsequently, alsoindependently from the cartridge 100 and/or the analysis device 200. Forthis purpose, in particular only the data connection DVD between theoperating instrument 400 and the database 500 is required. The retrieveddata can be stored temporarily in the memory 450.

It is preferable for the analysis device 200 to determine or read outthe cartridge identifier 100C and send it to the operating instrument400 before the test is carried out using a specific cartridge 100, evenif the operating instrument 400 has already previously retrieved orreceived control information 510, calibration information 520 and/orevaluation information 530. The cartridge identifier 100C transmittedfrom the analysis device 200 to the operating instrument 400 before thetest has begun can then be checked by the operating instrument 400 inorder to determine whether control information 510, calibrationinformation 520 and/or evaluation information 530 that corresponds tothe cartridge 100 and/or the cartridge identifier 100C is provided, inparticular already stored or temporarily stored in the memory 450.

If the operating instrument 400 identifies control information 510and/or calibration information 520 that already corresponds to thecartridge 100 or the cartridge identifier 100C, this information can betransmitted to the analysis device 200 and the test using the cartridge100 inserted into the analysis device 200 can be started.

Alternatively, required control information 510 and/or calibrationinformation 520 is retrieved from the database 500.

In a preferred development of the invention, the analysis system 1comprises a plurality of different cartridges 100 for carrying outpreferably different tests, to which different control information 510and evaluation information 530 corresponds.

For the same cartridge 100, different control information 510 and/orevaluation information 530 can be provided, selected, selectable,retrieved, retrievable, used and/or usable, in particular when differenttests can be carried out using the same cartridge 100, and the controlinformation 510 corresponds in each case to one of the tests that can becarried out.

In another aspect of the present invention, which can also beimplemented independently, a computer program product is provided thatcomprises program code means for carrying out the proposed method. Thiscomputer program product is in particular an instruction stored on astorage medium, in particular in the form of a smartphone app or thelike.

The instruction is preferably set up to control the operating instrument400, and/or to determine and/or receive the cartridge identifier 100C.

Alternatively, or additionally, the instruction is set up to control theoperating instrument 400, to transmit the cartridge identifier 100C tothe database 500, and to subsequently receive control information 510from the database 500.

Alternatively, or additionally, the instruction is designed to controlthe operating instrument 400 and/or to transmit or forward controlinformation 510 to the analysis device 200.

Alternatively, or additionally, the instruction is designed to controlthe operating instrument 400, and/or to receive, evaluate and/orinterpret measurement results 713, in particular using retrieved and/orreceived evaluation information 530.

In general, the analysis device 200, the cartridge 100 or in particularthe sensor apparatus 113 may measure, detect or identify the one or moreanalytes A by means of specific bonding, in particular by means ofcapture molecules and/or of means of electrochemical detection such asredox cycling, or the like, preferably performed on the cartridge 100and/or in the sensor apparatus 113. Preferably, the capture moleculesare arranged or immobilized on a sensor array or on sensor fields orelectrodes of the sensor apparatus 113. In particular, an immuno-assayor a protein assay for detecting or identifying a protein and/or anucleic-assay for detecting or identifying a nucleic-acid sequence canbe or is realized.

Alternatively, or additionally, measurements without specific bondingand/or without electrochemical detection can be used or performed,preferably in or by the analysis device 200 and/or cartridge 100. Suchmeasurements can include an optical measurement, impedance measurement,capacitance measurement, spectrometric measurement, mass spectrometricmeasurement, or the like. For this purpose, the analysis device 200 orcartridge 100 may comprise an optical spectrometer and/or allow opticalmeasurements of the treated or untreated sample P. Thus, it is possibleto measure, detect or identify other or further analytes A, compounds,material characteristics, or the like of the sample P, e.g. within thecartridge 100 or any other sample carrier. These alternative oradditional measurements can be used or processed and/or evaluated in asimilar manner as described or differently.

In particular, the present invention relates also to any one of thefollowing aspects which can be realized independently or in anycombination, also in combination with any aspects described above.

-   1. Analysis system 1 for testing an in particular biological sample    P,-   the analysis system 1 comprising a cartridge 100 for receiving the    sample P, and-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   characterized-   in that the analysis system 1 comprises an operating instrument 400    which preferably can be separated from the analysis device 200 with    respect to a data connection and/or wirelessly connected to the    analysis device 200,

the operating instrument 400 being designed to determine or receive acartridge identifier 100C corresponding to the cartridge 100 and, usingthis cartridge identifier 100C, to retrieve from a database 500 controlinformation 510 for carrying out the test and/or to transmit saidcontrol information 510 to the analysis device 200; and/or

the operating instrument 400 being designed to transmit to the analysisdevice 200 control information 510 for carrying out the test supportedby the cartridge 100, and the analysis device 200 being designed tocarry out the test using the transmitted control information 510independently and/or separately from the operating instrument 400;and/or

the analysis device 200 being designed to receive control information510 from the operating instrument 400, to control the test of the sampleP in the cartridge 100 using the control information 510 and to transmitmeasurement results 713 determined during the test to the operatinginstrument 400 without any prior evaluation; and/or

the operating instrument 400 being designed to determine or receive acartridge identifier 100C corresponding to the cartridge 100 and, usingthe cartridge identifier 100C, to retrieve from a database 500evaluation information 530 for evaluating measurement results 713determined during the test, and to evaluate the measurement results 713using the evaluation information 530 independently and/or separatelyfrom the analysis device 200.

-   2. Analysis system according to aspect 1, characterized in that the    cartridge 100 comprises a memory means 100D from which the cartridge    identifier 100C can be read out, preferably electronically, in    particular by means of the analysis device 200, and/or optically,    preferably by means of a camera 421 of the operating instrument 400,    the operating instrument 400 preferably being designed to    automatically retrieve from the database 500 the control information    510 for controlling the analysis device 200 in order to carry out    the test supported by the cartridge 100 and/or analysis information    530 for evaluating measurement results 713 determined by the test,    by the cartridge identifier 100C of the cartridge 100 being read out    or after the cartridge identifier 100C has been read out-   3. Analysis system according to aspect 1 or 2, characterized in that    the control information 510 and/or the evaluation information 530    comprises instructions, preferably in the form of an algorithm,    and/or the instructions forming a module which can be implemented by    the analysis device 200 and/or the operating instrument 400, as a    result of which the behavior of the analysis device 200 and/or of    the operating instrument 400 can be changed.-   4. Analysis system according to any one of the preceding aspects,    characterized in that the analysis device 200 is designed to control    apparatus of the analysis device 200 using the control information    510

such that the sample P is conveyed inside the cartridge 100 to a sensorapparatus 113 in a manner specified by the control information 510,and/or

such that valves 115 of the cartridge 100 are opened or closed in amanner specified by the control information 510, and/or

such that one or more temperature-control apparatus 204 of the analysisdevice 200 are controlled such that the sample P and/or a sensorapparatus 113 is temperature-controlled in a manner specified by thecontrol information 510.

-   5. Analysis system according to any one of the preceding aspects,    characterized in that the analysis device 200 comprises:

a receiver 210A for, preferably wirelessly, receiving the controlinformation 510 from the operating instrument 400, and/or

memory 207A for storing the control information 510, and/or

a control apparatus 207 for controlling and/or feedback controllingapparatus of the analysis device 200 in order to carry out the test,and/or

a connection apparatus 203 for establishing an electronic connection toa sensor apparatus 113 of the cartridge 100, and/or

a read-out module 207C for reading out measurement results 713 from thesensor apparatus 113 of the cartridge 100, and/or

a transmitter 210B for transmitting measurement results 713 read outfrom the sensor apparatus 113 to the operating instrument.

-   6. Analysis system according to any one of the preceding aspects,    characterized in that the operating instrument 400 comprises an    evaluation module 440 which is designed to evaluate measurement    results 713 read out from the sensor apparatus 113, preferably by    means of the evaluation information 530 retrieved from the database    500.-   7. Analysis system according to any one of the preceding aspects,    characterized in that the evaluation information 530 comprises    interpretation information 532 which assigns the measurement results    713 to physical variables such that the measurement results 713 can    be interpreted.-   8. Analysis system according to any of the preceding aspects,    characterized in that the sensor apparatus 113 comprises a plurality    of sensor fields 113B and the evaluation information 530 comprises    assignment information 531 for assigning each of the measurement    results 713 from the respective sensor fields 113B to a property of    the or a sensor type of the respective sensor fields 113B.-   9. Analysis system according to any one of the preceding aspects,    characterized in that the operating instrument 400 comprises an    output apparatus 410, preferably a display apparatus, in particular    a display 411, and is designed to output evaluation results 740 that    are determined, in particular calculated, by evaluating the    measurement results 713 using the evaluation information 530.-   10. Analysis system according to any one of the preceding aspects,    characterized in that the operating instrument 400 is designed to

transmit, to the analysis device 200, control information 510 forreceiving or ejecting the cartridge 100, and/or

transmit control information 510 to the analysis device 200 for startingthe test, and/or retrieve and/or receive measurement results 713 fromthe analysis device 200, and/or

send evaluation results 740 to a database 500.

-   11. Analysis system according to any one of the preceding aspects,    characterized in that the operating instrument 400 comprises an    input apparatus 420, in particular a touch-sensitive screen, by    means of which the transmission of commands and/or information to    the analysis device 200 can be triggered; and/or-   in that the operating instrument 400 and the analysis device 200    each comprise a wireless data interface 430, 210 which are designed    to jointly establish an ad-hoc data connection between the operating    instrument 400 and the analysis device 200, preferably such that,    when the operating instrument 400 and the analysis device 200    approach one another in space, the data connection (DVA)    therebetween is automatically established and is preferably    displayed by means of the operating instrument 400.-   12. Analysis system according to any one of the preceding aspects,    characterized in that the operating instrument 400 comprises    different interfaces 430 that are independent of one another for    establishing data connections (DVA, DVD) to the analysis device 200    and to the database 500, the analysis device 200, as a peripheral    device of the operating instrument 400, being designed to    communicate exclusively with or via the operating instrument 400.-   13. Analysis system according to any one of the preceding aspects,    characterized in that the analysis system 1 comprises a plurality of    different cartridges 100 for carrying out preferably different tests    to which different control information 510 and evaluation    information 530 corresponds.-   14. Method for testing, in particular, a biological sample P by    means of an analysis system 1, the analysis system 1 comprising a    cartridge 100 for receiving the sample P, the cartridge 100    comprising a sensor apparatus 113 for measuring sample-specific    measurement results and a fluid system for conveying the sample P to    the sensor apparatus 113,-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   characterized-   in that the analysis system 1 comprises an operating instrument 400    which preferably can be separated from the analysis device 200 with    respect to a data connection and/or wirelessly connected to the    analysis device 200,

the operating instrument 400 determining or receiving a cartridgeidentifier 100C corresponding to the cartridge 100 and, using thecartridge identifier 100C, retrieving from a database 500 controlinformation 510 for carrying out the test and/or transmitting saidcontrol information 510 to the analysis device 200; and/or

the operating instrument 400 transmitting to the analysis device 200control information 510 for carrying out the test supported by thecartridge 100, and the analysis device 200 carrying out the test usingthe transmitted control information 510 independently and/or separatelyfrom the operating instrument 400; and/or

the analysis device 200 receiving control information 510 from theoperating instrument 400, controlling the test of the sample P in thecartridge 100 using the control information 510 and transmittingmeasurement results 713 determined during the test to the operatinginstrument 400 without any prior evaluation; and/or

the operating instrument 400 determining or receiving a cartridgeidentifier 100C corresponding to the cartridge 100 and, using thecartridge identifier 100C, retrieving from a database 500 evaluationinformation 530 for evaluating measurement results 713 determined duringthe test, and evaluating the measurement results 713 using theevaluation information 530 independently and/or separately from theanalysis device 200.

-   15. Computer program product comprising program code means which,    when executed, cause the method steps of the method according to the    preceding aspect to be carried out.-   16. Method for testing, in particular, a biological sample P by    means of an analysis system 1,-   the analysis system 1 comprising a cartridge 100 for receiving the    sample P,-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   wherein the analysis system 1 comprises an operating instrument 400    which is separable from the analysis device 200 with respect to a    data connection and/or wirelessly connectable to the analysis device    200,-   the operating instrument 400 determining or reading out a cartridge    identifier 100C corresponding to the cartridge 100 and, using the    cartridge identifier 100C, retrieving from a database 500 control    information 510 for carrying out the test and transmitting said    control information 510 to the analysis device 200.-   17. Method for testing, in particular, a biological sample P by    means of an analysis system 1, preferably according to aspect 16,-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   wherein the analysis system 1 comprises an operating instrument 400    which is separable from the analysis device 200 with respect to a    data connection and/or wirelessly connectable to the analysis device    200,-   the operating instrument 400 retrieving from an external database    500 control information 510 for controlling actuators 202, 204, 205    of the analysis device 200 for carrying out the test supported by    the cartridge 100 and transmitting to the analysis device 200 said    control information 510, and the analysis device 200 carrying out    the test using the transmitted control information 510    independently, disconnected and/or separately from the operating    instrument 400.-   18. Method for testing an in particular biological sample P by means    of an analysis system 1, preferably according to aspect 16 or 17,-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   wherein the analysis system 1 comprises an operating instrument 400    which is separable from the analysis device 200 with respect to a    data connection and/or wirelessly connectable to the analysis device    200,-   the analysis device 200 receiving control information 510 from the    operating instrument 400, controlling the test of the sample P in    the cartridge 100 using the control information 510 and transmitting    measurement results 713 determined during the test to the operating    instrument 400 without any prior evaluation.-   19. Method for testing, in particular, a biological sample P by    means of an analysis system 1, preferably according to any one of    aspects 16 to 18,-   the analysis system 1 comprising an analysis device 200 for    receiving the cartridge 100 and subsequently carrying out the test    using the received cartridge 100,-   wherein the analysis system 1 comprises an operating instrument 400,    the operating instrument 400 determining, reading out or receiving a    cartridge identifier 100C corresponding to the cartridge 100 and,    using the cartridge identifier 100C, retrieving from a database 500    evaluation information 530 for evaluating measurement results 713    determined during the test, and evaluating the measurement results    713 using the evaluation information 530 independently, disconnected    and/or separately from the analysis device 200.-   20. Computer program product comprising program code means which,    when executed, cause the method steps of the method according to any    one of aspects 16 to 19 to be carried out.

Individual aspects and features of the present invention and individualmethod steps and/or method variants may be implemented independentlyfrom one another, but also in any desired combination and/or order.

What is claimed is:
 1. Analysis system for testing a biological sample,comprising: an analysis device, at least one cartridge for receiving thesample, said cartridge having a sensor apparatus configured to obtainmeasurement results from testing of the sample received in thecartridge, the cartridge further including electrical contacts fromwhich the measurement results from the testing of the sample can be readout or transmitted to the analysis device, and an operating instrumentwhich is connected to the analysis device by a disconnectable datainterface connection, wherein a memory is located inside of the sensorapparatus and in which a cartridge identifier corresponding to thecartridge is stored, wherein said sensor apparatus comprises a chiphaving electrochemical detection electrodes for detecting at least oneanalyte of the sample, wherein the analysis device is configured toreceive the cartridge and subsequently carry out the testing of thesample received inside the received cartridge, and wherein said analysisdevice further comprises a connection apparatus with electrical contactelements configured to establish an electronic connection to the sensorapparatus via the contacts on the cartridge, wherein the operatinginstrument is configured to retrieve the cartridge identifiercorresponding to the cartridge from said memory of the sensor apparatusvia said data interface connection and to use the cartridge identifierto retrieve evaluation information from a database for evaluating themeasurement results obtained by the sensor apparatus, wherein theanalysis device is configured to read out the measurement results fromthe sensor apparatus via the same connection apparatus by which thecartridge identification is read out from the memory and to transmit themeasurement results to the operating instrument via said data interfaceconnection, and wherein the operating instrument is configured toreceive the measurement results from the analysis device via said datainterface connection and to evaluate the measurement results using saidevaluation information to obtain evaluation results.
 2. Analysis systemaccording to claim 1, wherein the operating instrument is configured toperform the evaluation with the data interface connection disconnected.3. Analysis system according to claim 1, wherein the analysis device isconfigured to perform the testing with the data interface connectiondisconnected.
 4. Analysis system according to claim 1, wherein theanalysis device is configured to transmit the measurement results to theoperating instrument without any prior evaluation.
 5. Analysis systemaccording to claim 1, wherein the data interface connection is awireless connection.
 6. Analysis system according to claim 1, whereinthe evaluation information comprises a set of instructions that arecontained in a software module which can be implemented by the operatinginstrument, as a result of which operation of the operating instrumentis changed or changeable.
 7. Analysis system according to claim 6,wherein the instructions are commands, machine code, pre-compiled sourcecode or source code.
 8. Analysis system according to claim 6, whereinthe instructions are provided in a replaceable plugin unit
 9. Analysissystem according to claim 1, wherein the operating instrument comprisesan output apparatus and is configured to output the evaluation resultsvia the output apparatus.
 10. Analysis system according to claim 1,wherein the operating instrument comprises an input apparatus by meansof which the transmission of commands or information to the analysisdevice is triggerable.
 11. Analysis system according to claim 1, whereinthe operating instrument comprises different interfaces that areindependent of one another for establishing data connections to theanalysis device and to the database, and wherein the analysis device isa peripheral device of the operating instrument and is configured tocommunicate exclusively with or via the operating instrument 12.Analysis system according to claim 1, wherein the operating instrumentis configured to send the evaluation results to the at least onedatabase.
 13. Analysis system according to claim 1, wherein saidoperating instrument is separable from the analysis device with respectto the at least one database.
 14. Analysis system according to claim 1,wherein the analysis system comprises said at least one cartridge thatis configured for carrying out different tests or said at least onecartridge comprises a plurality of different cartridges configured forcarrying out different tests, wherein different pieces of evaluationinformation correspond to one or more of said different tests or tomeasurement results resulting therefrom.
 15. Analysis system accordingto claim 1, wherein the analysis device is configured to control atleast one apparatus of the analysis device by which the sample isconveyed inside the cartridge to the sensor apparatus, or valves of thecartridge are opened or closed, or one or more temperature-controlapparatuses of the analysis device such that the sample and/or thesensor apparatus is temperature-controlled.
 16. Analysis system fortesting a biological sample, comprising: a cartridge for receiving thesample, an analysis device configured to receive the cartridge andsubsequently carry out the testing of the sample received inside thereceived cartridge, an operating instrument which is connected to theanalysis device by a disconnectable data interface connection, and atleast one of control information by means of which the analysis deviceis controllable to carry out the testing of the sample received in thecartridge or evaluation information for evaluating measurement resultsobtained from the testing of the sample received in the cartridge,wherein the at least one of the control information or the evaluationinformation comprises instructions that are implementable by at leastone of the analysis device or the operating instrument for changingoperation of the at least one of the analysis device or the operatinginstrument, and wherein the instructions are provided in a replaceablesoftware module for at least one of the operating instrument or theanalysis device.
 17. Analysis system according to claim 16, wherein theinstructions are at least one of commands, machine code, pre-compiledsource code or source code.
 18. Analysis system according to claim 16,wherein the instructions are provided in a replaceable plugin unit. 19.Analysis system according to claim 16, wherein the control informationcomprises a set of instructions that are contained in a software modulewhich can be implemented by the analysis device, as a result of whichoperation of the analysis device is changed or changeable.
 20. Analysissystem according to claim 16, wherein the evaluation informationcomprises a set of instructions that are contained in a software modulewhich can be implemented by the operating instrument, as a result ofwhich operation of the operating instrument is changed or changeable.